Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | May 22, 2013 | Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by:… | Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is… | Legacy Pharmaceutical Packaging LLC | Terminated |
| Class II | May 22, 2013 | Methylcobalamin Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class I | May 22, 2013 | libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs,… | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA… | Performance Plus Marketing, Inc. | Terminated |
| Class I | May 22, 2013 | Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health… | Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA… | Evol Nutrition | Terminated |
| Class II | May 22, 2013 | Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations including DMSO… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class I | May 22, 2013 | ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8)… | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue… | Consumer Concepts, Inc. | Terminated |
| Class II | May 22, 2013 | Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1%… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL,… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | L-Carnitine Injection, all strengths and all presentations including L-Carnitine 500… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Metoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Medroxyprogesterone Acetate Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Hydroxocobalamin Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Edetate Calcium Disodium Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Nandrolone Decanoate Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Sodium Chloride Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Thiamine Hydrochloride Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only,… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Methylprednisolone Acetate Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class I | May 22, 2013 | a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs… | Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an… | InSo-Independent Contractor for West Coast Nutritionals,LTD | Terminated |
| Class II | May 22, 2013 | Betamethasone Combination Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Bupivacaine and Dexamethasone Injection, all strengths and all presentations including… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative… | Lack of Assurance of Sterility; reports of adverse events after injection | NuVision Pharmacy, Inc. | Terminated |
| Class I | May 22, 2013 | Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs,… | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA… | Performance Plus Marketing, Inc. | Terminated |
| Class II | May 22, 2013 | Procaine Hydrochloride Injection, all strengths and all presentations, including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Methylprednisolone and Bupivacaine Injection, all strengths and all presentations… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class I | May 22, 2013 | Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley… | Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of… | Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Edetate Disodium Injection, all strengths and all presentations including a) Edetate… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class I | May 22, 2013 | Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL… | Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of… | Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Manganese Sulfate Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Hydroxyprogesterone Caproate Injection, all strengths and all presentations including… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2%… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class I | May 22, 2013 | Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister… | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA… | Performance Plus Marketing, Inc. | Terminated |
| Class II | May 22, 2013 | Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Lidocaine Injection, all strengths and all presentations including a) Lidocaine… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Testosterone Cypionate Injection, all strengths and all presentations including a)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Progesterone Injection, all strengths and all presentations including a) Progesterone 100… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b)… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class III | May 22, 2013 | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol… | Subpotent; Cetylpyridinum Chloride | Hi-Tech Pharmacal Co., Inc. | Terminated |
| Class II | May 22, 2013 | Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class II | May 22, 2013 | Sodium Chloride and Dexamethasone Injection, all strengths and all presentations… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class I | May 22, 2013 | BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs,… | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA… | Performance Plus Marketing, Inc. | Terminated |
| Class I | May 22, 2013 | Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister… | Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved… | D& S Herbals, LLC | Terminated |
| Class I | May 22, 2013 | BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement,… | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA… | Performance Plus Marketing, Inc. | Terminated |
| Class III | May 22, 2013 | PRAVASTATIN SODIUM Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only,… | Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described… | Glenmark Generics Inc., USA | Terminated |
| Class II | May 22, 2013 | Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium… | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… | FVS Holdings, Inc. dba. Green Valley Drugs | Terminated |
| Class III | May 22, 2013 | Gabapentin Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg,… | Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as… | Glenmark Generics Inc., USA | Terminated |
| Class III | May 22, 2013 | topiramate Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only,… | Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as… | Glenmark Generics Inc., USA | Terminated |
| Class III | May 15, 2013 | Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by:… | Failed Impurities/Degradation Specifications: 3 month stability testing. | L. Perrigo Co. | Terminated |
| Class III | May 15, 2013 | Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by… | Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA). | Physicians Total Care, Inc. | Terminated |
| Class II | May 15, 2013 | Furosemide Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA,… | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. | Terminated |
| Class II | May 15, 2013 | sodium acetate Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx… | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. | Terminated |
| Class II | May 15, 2013 | DIAZEPAM Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA,… | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. | Terminated |
| Class II | May 15, 2013 | QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only,… | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. | Terminated |
| Class III | May 8, 2013 | Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count… | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration… | Warner Chilcott Company LLC | Terminated |
| Class III | May 8, 2013 | Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians… | Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25… | Physicians Total Care, Inc. | Terminated |
| Class II | May 8, 2013 | Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only… | Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The… | West-ward Pharmaceutical Corp. | Terminated |
| Class III | May 8, 2013 | Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90… | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration… | Warner Chilcott Company LLC | Terminated |
| Class II | May 8, 2013 | Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0… | CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under… | Carib Import & Export, Inc. | Terminated |
| Class III | May 8, 2013 | Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count… | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration… | Warner Chilcott Company LLC | Terminated |
| Class III | May 8, 2013 | Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC… | Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine. | Reckitt Benckiser Inc | Terminated |
| Class II | May 8, 2013 | "Well at Wallgreens" Regular Strength Antacid Liquid… | Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of… | Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals | Terminated |
| Class III | May 8, 2013 | Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc.,… | Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station. | Hi-Tech Pharmacal Co., Inc. | Terminated |
| Class II | May 8, 2013 | Daytrana Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1… | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | May 8, 2013 | Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by… | cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices. | Jubilant Cadista Pharmaceuticals Inc. | Terminated |
| Class II | May 8, 2013 | DIAZEPAM Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA,… | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. | Terminated |
| Class II | May 8, 2013 | Morphine Sulfate Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx… | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial | Hospira Inc. | Terminated |
| Class II | May 1, 2013 | Amoxicillin Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc.,… | Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential… | Sandoz Incorporated | Terminated |
| Class II | May 1, 2013 | 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions,… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class I | May 1, 2013 | WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health… | Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary… | Brower Enterprises Inc | Terminated |
| Class II | May 1, 2013 | Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz… | Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the… | OPMX, LLC | Terminated |
| Class II | May 1, 2013 | Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding… | Lack of Sterility Assurance | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for:… | Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the… | Qualitest Pharmaceuticals | Terminated |
| Class II | May 1, 2013 | BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class III | May 1, 2013 | Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan… | Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the… | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | May 1, 2013 | Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets,… | Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the… | OPMX, LLC | Terminated |
| Class II | May 1, 2013 | Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a… | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding… | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Terminated |
| Class II | May 1, 2013 | propofol Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion… | Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection. | Hospira Inc. | Terminated |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles… | Chemical contamination: emission of strong odor after package was opened | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles… | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. | Completed |
| Class I | April 24, 2013 | Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS | Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active… | The Menz Club, LLC | Ongoing |
| Class I | April 24, 2013 | Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only,… | Non-Sterility: Confirmed customer complaint of product contaminated with mold. | Hospira Inc. | Terminated |
| Class I | April 24, 2013 | Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only,… | Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold. | Hospira Inc. | Terminated |
| Class II | April 24, 2013 | Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC… | Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the… | Precision Dose Inc. | Terminated |
| Class I | April 24, 2013 | Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics,… | Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for… | Body Basics Inc | Terminated |
| Class III | April 24, 2013 | buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per… | Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing… | Actavis South Atlantic LLC | Terminated |
| Class III | April 24, 2013 | Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when… | Discoloration; Product may not meet specifications for color description once reconstituted. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC… | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles… | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC… | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles… | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles… | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC… | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC… | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles… | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles… | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. | Completed |
| Class II | April 24, 2013 | Copaxone Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED… | Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints… | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class II | April 17, 2013 | Cefdinir Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC… | Defective Container: This recall is being carried out due to the potential for improperly sealed bottles. | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class II | April 17, 2013 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and… | Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in… | Gsms | Terminated |
| Class III | April 17, 2013 | Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count… | Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for… | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class III | April 17, 2013 | Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per… | Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for… | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class II | April 10, 2013 | Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100… | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products | Terminated |
| Class II | April 10, 2013 | Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC… | Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed… | Dr Reddys Laboratories Tennessee LLC | Terminated |
| Class II | April 10, 2013 | Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC,… | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products | Terminated |
| Class II | April 10, 2013 | Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only,… | Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months. | West-ward Pharmaceutical Corp. | Terminated |
| Class II | April 10, 2013 | Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler,… | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products | Terminated |
| Class II | April 10, 2013 | 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest,… | Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without… | Hospira Inc. | Terminated |
| Class III | April 10, 2013 | TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only.… | Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin… | Ferring Pharmaceuticals Inc | Terminated |
| Class II | April 10, 2013 | BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC,… | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products | Terminated |
| Class II | April 10, 2013 | Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60… | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products | Terminated |
| Class II | April 10, 2013 | Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60… | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products | Terminated |
| Class II | April 10, 2013 | NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle,… | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products | Terminated |
| Class II | April 10, 2013 | CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6… | Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content… | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class III | April 10, 2013 | Ketoconazole Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a… | Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by… | Fougera Pharmaceuticals Inc. | Terminated |
| Class III | April 10, 2013 | Tizanidine Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's… | Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as… | Dr. Reddy'S Laboratories | Terminated |
| Class II | April 3, 2013 | Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine… | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is… | CareFusion 213, LLC | Terminated |
| Class II | April 3, 2013 | SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide… | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is… | CareFusion 213, LLC | Terminated |
| Class II | April 3, 2013 | SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL… | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is… | CareFusion 213, LLC | Terminated |
| Class II | April 3, 2013 | Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1… | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is… | CareFusion 213, LLC | Terminated |
| Class III | April 3, 2013 | Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill… | Subpotent; 12 month stability timepoint | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 3, 2013 | PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan… | Subpotent; 12 month time point for the active ingredient Phenylephrine HCl. | L. Perrigo Co. | Terminated |
| Class II | April 3, 2013 | SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified… | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is… | CareFusion 213, LLC | Terminated |
| Class II | April 3, 2013 | PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA… | Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. | Physicians Total Care, Inc. | Terminated |
| Class III | April 3, 2013 | Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake… | CGMP Deviations: Shipment of product not approved for release. | Hospira, Inc. | Terminated |
| Class III | April 3, 2013 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR… | Subpotent; 22 month stability timepoint | Hill Dermaceuticals, Inc. | Terminated |
| Class II | April 3, 2013 | FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1… | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is… | CareFusion 213, LLC | Terminated |
| Class II | April 3, 2013 | PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA… | Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. | Physicians Total Care, Inc. | Terminated |
| Class II | April 3, 2013 | Venlafaxine Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only,… | Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in… | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | April 3, 2013 | Ciprofloxacin Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward… | Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet. | West-ward Pharmaceutical Corp. | Terminated |
| Class III | April 3, 2013 | TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a… | Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials. | Pfizer Inc. | Terminated |
| Class II | April 3, 2013 | propofol Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials… | Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle… | Hospira Inc. | Terminated |
| Class III | March 27, 2013 | Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC… | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health | Terminated |
| Class II | March 27, 2013 | METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake… | Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the… | Hospira Inc. | Terminated |
| Class III | March 27, 2013 | 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC.… | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health | Terminated |
| Class II | March 27, 2013 | Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson… | Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of… | Watson Laboratories Inc | Terminated |
| Class III | March 27, 2013 | 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%,… | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health | Terminated |
| Class III | March 27, 2013 | Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube,… | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health | Terminated |
| Class II | March 27, 2013 | Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson… | Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of… | Watson Laboratories Inc | Terminated |
| Class II | March 27, 2013 | Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx,… | Subpotent; 15 month stability (by mfr) | Physicians Total Care, Inc. | Terminated |
| Class II | March 27, 2013 | ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet… | Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . | Watson Laboratories Inc | Terminated |
| Class III | March 27, 2013 | Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured… | Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product… | West-ward Pharmaceutical Corp. | Terminated |
| Class III | March 27, 2013 | 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride… | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health | Terminated |
| Class II | March 20, 2013 | Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL,… | CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures. | RX South LLC DBA RX3 Pharmacy | Terminated |
| Class III | March 20, 2013 | CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For… | Labeling: Missing label | Fresenius Kabi USA LLC (FK USA) | Terminated |
| Class II | March 20, 2013 | Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%,… | Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label… | K C Pharmaceuticals Inc | Terminated |
| Class II | March 20, 2013 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain… | Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia… | Humco Holding Group, Inc | Terminated |
| Class II | March 20, 2013 | ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60… | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. | Terminated |
| Class II | March 20, 2013 | Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC… | Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle. | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class II | March 20, 2013 | PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240… | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. | Terminated |
| Class II | March 20, 2013 | PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams… | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. | Terminated |
| Class III | March 20, 2013 | PULMICORT RESPULES PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC:… | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. | AstraZeneca LP | Terminated |
| Class III | March 20, 2013 | PULMICORT RESPULES PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC:… | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. | AstraZeneca LP | Terminated |
| Class III | March 13, 2013 | Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan… | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.… | Aaron Industries Inc | Terminated |
| Class III | March 13, 2013 | Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10… | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.… | Aaron Industries Inc | Terminated |
| Class III | March 13, 2013 | Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan… | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.… | Aaron Industries Inc | Terminated |
| Class III | March 13, 2013 | Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom… | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.… | Aaron Industries Inc | Terminated |
| Class II | March 13, 2013 | 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC… | Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill… | Hospira Inc. | Terminated |
| Class II | March 13, 2013 | VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90… | Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored. | West-ward Pharmaceutical Corp. | Terminated |
| Class III | March 13, 2013 | Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC… | Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and… | Glenmark Generics Inc., USA | Terminated |
| Class II | March 13, 2013 | ABILIFY ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka… | CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the… | Bristol Myers Squibb Manufacturing Company | Terminated |
| Class III | March 13, 2013 | Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution… | Actavis Elizabeth LLC | Terminated |
| Class II | March 13, 2013 | HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED… | Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the… | Hospira Inc. | Terminated |
| Class II | March 6, 2013 | Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's… | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong… | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | March 6, 2013 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only,… | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product… | Amedra Pharmaceuticals LLC | Terminated |
| Class II | March 6, 2013 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only,… | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product… | Amedra Pharmaceuticals LLC | Terminated |
| Class II | March 6, 2013 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only,… | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product… | Amedra Pharmaceuticals LLC | Terminated |
| Class II | March 6, 2013 | Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194… | Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. | West-ward Pharmaceutical Corp. | Terminated |
| Class III | March 6, 2013 | buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx… | Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. | Actavis Pharmaceuticals | Terminated |
| Class II | March 6, 2013 | Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100… | Failed Dissolution Specifications; 36 month stability timepoint | West-ward Pharmaceutical Corp. | Terminated |
| Class III | March 6, 2013 | Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400… | Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton… | Bayer Healthcare, LLC | Terminated |
| Class II | March 6, 2013 | 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira,… | Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the… | Hospira Inc. | Terminated |
| Class II | March 6, 2013 | EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL)… | Subpotent; bupivacaine | Pacira Pharmaceuticals, Inc. | Terminated |
| Class II | March 6, 2013 | Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's… | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong… | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | March 6, 2013 | Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's… | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong… | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | March 6, 2013 | Furosemide Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc.,… | Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial | Hospira, Inc. | Terminated |
| Class I | February 27, 2013 | SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda… | Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because… | P & J Trading Co | Terminated |
| Class III | February 27, 2013 | Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by… | Cross Contamination with Other Products: Product was mixed with another type of mouth wash. | Procter & Gamble Hair Care Llc | Terminated |
| Class I | February 27, 2013 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x… | Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and… | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Terminated |
| Class III | February 20, 2013 | Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy,… | Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some… | Ranbaxy Inc. | Terminated |
| Class II | February 20, 2013 | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only,… | Failed Dissolution Test Requirements | Upsher Smith Laboratories, Inc. | Terminated |
| Class III | February 20, 2013 | Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC… | Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some… | Ranbaxy Inc. | Terminated |
| Class III | February 20, 2013 | Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by:… | Subpotent Drug | West-ward Pharmaceutical Corp. | Terminated |
| Class II | February 20, 2013 | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled… | Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled… | Lee Pharmaceuticals, Inc | Terminated |
| Class II | February 20, 2013 | propofol Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200… | Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain… | Hospira Inc. | Terminated |
| Class I | February 13, 2013 | SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product… | Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was… | Globe All Wellness, LLC | Terminated |
| Class I | February 13, 2013 | Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100… | Presence of Particulate Matter; fibers identified as cellulose and polyvinyl | Bracco Diagnostic Inc | Terminated |
| Class III | February 13, 2013 | EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression,… | Defective Container: Pump head detaching from the canister unit upon removal of the overcap. | Ascend Therapeutics Inc | Terminated |
| Class I | February 13, 2013 | Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx… | Presence of Particulate Matter; fibers identified as cellulose and polyvinyl | Bracco Diagnostic Inc | Terminated |
| Class III | February 13, 2013 | ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant… | Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life,… | Estee Lauder Inc | Terminated |
| Class II | February 13, 2013 | Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC… | Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. | West-ward Pharmaceutical Corp. | Terminated |
| Class III | February 13, 2013 | Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards,… | Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of… | Sandoz Incorporated | Terminated |
| Class III | February 13, 2013 | Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown,… | Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date… | Stat Rx USA | Terminated |
| Class III | February 13, 2013 | Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by:… | Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred… | Bayer HealthCare Pharmaceuticals Inc. | Terminated |
| Class I | February 13, 2013 | Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15… | Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia. | Matrixx Initiatives Inc | Terminated |
| Class II | February 13, 2013 | PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC… | Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets. | West-ward Pharmaceutical Corp. | Terminated |
| Class I | February 13, 2013 | Carboplatin Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile,… | Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection.… | Hospira Inc. | Completed |
| Class I | February 13, 2013 | Carboplatin Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile,… | Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection.… | Hospira Inc. | Completed |
| Class II | February 13, 2013 | lansoprazole Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx… | Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100… | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | February 13, 2013 | Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90… | Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing.… | Watson Pharmaceuticals | Terminated |
| Class III | February 13, 2013 | Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per… | Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. | Actelion Pharmaceuticals U.S., Inc. | Terminated |
| Class III | February 6, 2013 | Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by… | Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles | Warner Chilcott Company LLC | Terminated |
| Class III | February 6, 2013 | Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by… | Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles | Warner Chilcott Company LLC | Terminated |