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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
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II January 3, 2018 Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class II January 3, 2018 Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL,… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class II January 3, 2018 Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class II January 3, 2018 Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class III January 3, 2018 Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for… Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant… Keryx Biopharmaceuticals, Inc. Terminated
Class II December 27, 2017 Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet… Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert,… Teva Pharmaceuticals USA Terminated
Class I December 27, 2017 LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body… Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted… EZWeightLossTX LLC Terminated
Class III December 27, 2017 Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC… Superpotent Renaissance Lakewood, LLC Terminated
Class II December 27, 2017 NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile… Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Advanced Pharma Inc. Terminated
Class I December 27, 2017 NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile… Subpotent Drug: found to be below the specification for labeled assay. Advanced Pharma Inc. Terminated
Class I December 27, 2017 NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL… Subpotent Drug: found to be below the specification for labeled assay. Advanced Pharma Inc. Terminated
Class II December 27, 2017 NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single… Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Advanced Pharma Inc. Terminated
Class II December 27, 2017 NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile… Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Advanced Pharma Inc. Terminated
Class II December 27, 2017 Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel… Microbial Contamination of Non-Sterile Products L. Perrigo Company Terminated
Class I December 27, 2017 NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per… Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil… The Ampt Life, LLC Terminated
Class II December 27, 2017 NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL… Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Advanced Pharma Inc. Terminated
Class II December 27, 2017 Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable… Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data. Premier Pharmacy Labs Inc Terminated
Class I December 27, 2017 NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile… Subpotent Drug: found to be below the specification for labeled assay. Advanced Pharma Inc. Terminated
Class II December 27, 2017 All Sterile Products within expiry Lack of Assurance of Sterility . Vital Rx, Inc. dba Atlantic Pharmacy and Compounding Terminated
Class I December 27, 2017 LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body… Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted… EZWeightLossTX LLC Terminated
Class II December 27, 2017 Acetic Acid 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun… Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture… B. Braun Medical Inc Terminated
Class I December 27, 2017 Lorazepam Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal… Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. Amneal Pharmaceuticals of New York, LLC Terminated
Class III December 27, 2017 Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2… Superpotent Claris Lifesciences Inc Terminated
Class I December 27, 2017 Vancomycin Hydrochloride Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira,… Presence of Particulate Matter: glass particulate found in vial Pfizer Inc. Terminated
Class III December 27, 2017 Methylphenidate Hydrochloride Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx… Subpotent Drug Osmotica Pharmaceutical Corp Terminated
Class III December 27, 2017 Methylphenidate Hydrochloride Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx… Subpotent Drug Osmotica Pharmaceutical Corp Terminated
Class III December 20, 2017 Penicillin V Potassium Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when… Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total… Teva Pharmaceuticals USA Terminated
Class II December 20, 2017 Riomet Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz.… Microbial Contamination of Non-Sterile Products Sun Pharmaceutical Industries, Inc. Terminated
Class I December 13, 2017 Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for:… Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride… International Laboratories, Inc. Terminated
Class I December 13, 2017 RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets,… Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil… Gadget Island, Inc Terminated
Class I December 13, 2017 grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg,… Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil… Gadget Island, Inc Terminated
Class I December 13, 2017 PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX… Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil… Gadget Island, Inc Terminated
Class I December 13, 2017 FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed… Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil… Gadget Island, Inc Terminated
Class III December 13, 2017 Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite… Failed Impurities/Degradation Specifications Elite Laboratories Inc. Terminated
Class II December 6, 2017 Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by:… Failed Tablet/Capsule Specifications; potential presence of broken tablets. Teva Pharmaceuticals USA Terminated
Class II December 6, 2017 Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by… Failed Dissolution Specifications. Mayne Pharma Inc Terminated
Class II December 6, 2017 Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide… CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to… EAI-JR286 INC Terminated
Class II December 6, 2017 No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed… Marketed Without an Approved NDA/ANDA NEW RELIANCE TRADING, INC. Terminated
Class II December 6, 2017 Levetiracetam Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx… Presence of foreign substance (screw) Hetero Labs, Ltd. - Unit III Terminated
Class II December 6, 2017 Paroxetine Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC… Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets Zydus Pharmaceuticals USA Inc Terminated
Class III December 6, 2017 Duloxetine Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured… Failed Dissolution Specification Lupin Pharmaceuticals Inc. Terminated
Class II November 29, 2017 Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz… GMP Deviations: inadequate manufacturing control processes Ridge Properties, LLC Terminated
Class II November 29, 2017 Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09),… GMP Deviations: inadequate manufacturing control processes Ridge Properties, LLC Terminated
Class II November 29, 2017 Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%),… GMP Deviations: inadequate manufacturing control processes Ridge Properties, LLC Terminated
Class II November 29, 2017 Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL… GMP Deviations: inadequate manufacturing control processes Ridge Properties, LLC Terminated
Class II November 29, 2017 Lorazepam Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading… Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam Leading Pharma, LLC Terminated
Class II November 29, 2017 No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed… Marketed Without an Approved NDA/ANDA Shata Trading, Inc. Terminated
Class II November 29, 2017 TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso… CGMP Deviations United Therapeutics Corp. Terminated
Class II November 29, 2017 PRAVASTATIN SODIUM Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin… Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one… Lupin Limited Terminated
Class II November 29, 2017 Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz… GMP Deviations: inadequate manufacturing control processes Ridge Properties, LLC Terminated
Class III November 29, 2017 Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01),… Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related… West-Ward Pharmaceuticals Corp. Terminated
Class III November 29, 2017 Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC… Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related… West-Ward Pharmaceuticals Corp. Terminated
Class II November 29, 2017 Paroxetine Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American… Presence of Foreign Tablets/Capsules. Amerisource Health Services Terminated
Class III November 22, 2017 Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan,… Failed Impurities/Degradation Specifications. Allergan Sales, LLC Terminated
Class III November 22, 2017 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and… Failed Stability Specifications Amerisource Health Services Terminated
Class II November 22, 2017 Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in… Superpotent drug: out of specification result for potency PharMEDium Services, LLC. Terminated
Class II November 22, 2017 Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2… Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could… Llorens Pharmaceutical Corp. Terminated
Class II November 22, 2017 Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b)… cGMP Deviations: lack of quality assurance at the API manufacturer. Fagron, Inc Terminated
Class III November 22, 2017 Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd.… Labeling: Incorrect or Missing Package Insert. Genzyme Corporation Terminated
Class III November 22, 2017 Meclizine Hydrochloride Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only,… Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III November 22, 2017 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only,… Failed Impurities/Degradation Specifications. Allergan Sales, LLC Terminated
Class II November 22, 2017 Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial,… Presence of Particulate Matter Amneal Pharmaceuticals LLC Terminated
Class III November 15, 2017 Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%),… Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number… Dr. Reddy's Laboratories, Inc. Terminated
Class II November 15, 2017 Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE… Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag Ace Surgical Supply Co., Inc. Terminated
Class II November 15, 2017 Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products… Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the… Purdue Pharma, LP Terminated
Class II November 8, 2017 oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per… Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. AVKARE Inc. Terminated
Class III November 8, 2017 Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59),… Subpotent Drug: low out of specification results. Precision Dose Inc. Terminated
Class II November 8, 2017 Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle… Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution… Teva Pharmaceuticals USA Terminated
Class II November 8, 2017 fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class II November 8, 2017 A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim… Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine,… Kiriko, LLC. Terminated
Class II November 8, 2017 morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single… Lack Of Assurance Of Sterility. SCA Pharmaceuticals, LLC Terminated
Class III November 8, 2017 Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva… Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for… Sanofi-Aventis U.S. LLC Terminated
Class I November 1, 2017 MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions,… Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA… Vitility Terminated
Class II November 1, 2017 Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only,… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx… Subpotent Drug Pharmedium Services, LLC Terminated
Class III November 1, 2017 Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by:… Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related… Wockhardt Usa Inc. Terminated
Class II November 1, 2017 Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only ,… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only,… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only,… Subpotent Drug Pharmedium Services, LLC Terminated
Class I November 1, 2017 Intralipid Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius… Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the… Baxter Healthcare Corporation Terminated
Class II November 1, 2017 Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only,… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded… Subpotent Drug Pharmedium Services, LLC Terminated
Class III November 1, 2017 Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only,… Failed Dissolution Specifications: Low out of specification results for dissolution. Teva Pharmaceuticals USA Terminated
Class II November 1, 2017 Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only,… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class III November 1, 2017 Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by:… Failed Stability Specifications Vi-Jon, Inc. Terminated
Class II November 1, 2017 Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only ,… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only,… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only,… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only,… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only,… Subpotent Drug Pharmedium Services, LLC Terminated
Class I November 1, 2017 PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured… Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone. Lucky Mart Inc. Terminated
Class II November 1, 2017 Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only… Subpotent Drug Pharmedium Services, LLC Terminated
Class II November 1, 2017 Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class II November 1, 2017 Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W… Lack of Assurance of Sterility. Banner Pharmacy Services, LLC Terminated
Class III November 1, 2017 ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd.,… Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of… Aidarex Pharmaceuticals LLC Terminated
Class III November 1, 2017 AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per… Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. AbbVie Inc. Terminated
Class II November 1, 2017 ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct… Becton Dickinson & Company Terminated
Class III November 1, 2017 AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per… Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. AbbVie Inc. Terminated
Class III November 1, 2017 Fluocinonide Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc.… Cross contamination with other products: traces of Dapsone were found in the finished product. Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II October 25, 2017 methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding,… Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the… RXQ Compounding LLC Terminated
Class II October 25, 2017 Bisoprolol fumarate Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM… Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18… Unichem Pharmaceuticals Usa Inc Terminated
Class II October 25, 2017 Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only,… Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. The Harvard Drug Group Terminated
Class II October 25, 2017 Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b:… Lack of Assurance of Sterility Deserving Health International Corp Terminated
Class II October 18, 2017 Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For… CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were… United Pharmacy Terminated
Class III October 18, 2017 Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by:… Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert. Boehringer Ingelheim Pharmaceuticals, Inc. Terminated
Class III October 18, 2017 Famotidine Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy… Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related… Dr. Reddy's Laboratories, Inc. Terminated
Class II October 11, 2017 Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800… GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm… Inopak Ltd Terminated
Class II October 11, 2017 Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz.… GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm… Inopak Ltd Terminated
Class III October 11, 2017 Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial.… CGMP Deviations: Firm failed to control impurity for color change at the API stage. Pfizer Inc. Terminated
Class II October 11, 2017 Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve,… GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm… Inopak Ltd Terminated
Class III October 11, 2017 Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz.… Failed Impurities/Degradation Specifications. Vi-Jon, Inc. Terminated
Class III October 11, 2017 Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz (… Failed Impurities/Degradation Specifications. Vi-Jon, Inc. Terminated
Class II October 4, 2017 Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig:… Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate… RemedyRepack Inc. Terminated
Class II October 4, 2017 Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta)… Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product… Teva Pharmaceuticals USA Terminated
Class II October 4, 2017 Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by… Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. Pfizer Inc. Terminated
Class III October 4, 2017 Ampicillin Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged… Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing… Sandoz Inc Terminated
Class III September 27, 2017 Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL… Failed Dissolution Specifications Pfizer Inc. Terminated
Class II September 27, 2017 Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total… Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to… PharMedium Services, Llc Terminated
Class II September 27, 2017 Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged… CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use. Medisca, Inc. Terminated
Class I September 27, 2017 Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1… Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. Genentech, Inc. Terminated
Class II September 27, 2017 Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total… Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to… PharMedium Services, Llc Terminated
Class III September 27, 2017 Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL… Failed Dissolution Specifications Pfizer Inc. Terminated
Class II September 27, 2017 PROCRIT Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials… Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection. Amgen, Inc. Terminated
Class II September 27, 2017 LEVOPHED Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL… Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing… Pfizer Inc. Terminated
Class II September 27, 2017 HYDROMORPHONE HYDROCHLORIDE HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25… Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing… Pfizer Inc. Terminated
Class II September 27, 2017 Daytrana Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx… Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. Noven Pharmaceuticals, Inc. Terminated
Class II September 27, 2017 Daytrana Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx… Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. Noven Pharmaceuticals, Inc. Terminated
Class II September 27, 2017 Daytrana Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx… Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. Noven Pharmaceuticals, Inc. Terminated
Class II September 27, 2017 Daytrana Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx… Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. Noven Pharmaceuticals, Inc. Terminated
Class III September 20, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry… Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class… VistaPharm, Inc. Terminated
Class II September 20, 2017 Paroxetine Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila… Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets Zydus Pharmaceuticals USA Inc Terminated
Class I September 20, 2017 Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30… Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil Chiavna Saffron LLC Terminated
Class I September 20, 2017 ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and… Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. Andropharm, LLC Terminated
Class I September 20, 2017 ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged… Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. Andropharm, LLC Terminated
Class II September 20, 2017 Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5… Microbial contamination of Non-sterile Products; potential B. cepacia contamination Centurion Labs, LLC Terminated
Class II September 20, 2017 Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine… CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… Mid Valley Pharmaceutical Terminated
Class II September 20, 2017 Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and… CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… Mid Valley Pharmaceutical Terminated
Class II September 20, 2017 MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago,… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago,… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class III September 20, 2017 Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex… Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30… Aidarex Pharmaceuticals LLC Terminated
Class II September 20, 2017 Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave.,… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago,… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class I September 20, 2017 New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and… Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk. BESTHERBS COFFEE LLC Terminated
Class II September 20, 2017 Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave.,… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class II September 20, 2017 Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave.,… Lack of Assurance of Sterility. Bella Pharmaceuticals, Inc. Terminated
Class III September 20, 2017 Amlodipine Besylate AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by:… PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine… Ascend Laboratories LLC Terminated
Class II September 20, 2017 Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g),… Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and… MEDLINE INDUSTRIES INC Terminated
Class II September 20, 2017 Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl.… Microbial contamination of Non-sterile Products; potential B. cepacia contamination Centurion Labs, LLC Terminated
Class III September 13, 2017 Famotidine Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for:… CGMP Deviations Lupin Pharmaceuticals Inc. Terminated
Class III September 13, 2017 Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count… Failed moisture limits: Out of specification for moisture content. Mckesson Packaging Services Terminated
Class II September 13, 2017 Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle,… Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier ImprimisRx CA, Inc., dba ImprimisRx Terminated
Class II September 13, 2017 Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured… Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had… Degasa Sa De Cv Terminated
Class II September 13, 2017 Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV… Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier ImprimisRx CA, Inc., dba ImprimisRx Terminated
Class II September 13, 2017 Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for… Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier ImprimisRx CA, Inc., dba ImprimisRx Terminated
Class II September 13, 2017 Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile… Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier ImprimisRx CA, Inc., dba ImprimisRx Terminated
Class II September 6, 2017 Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx… Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples. Amphastar Pharmaceuticals, Inc. Terminated
Class II September 6, 2017 Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100… Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove… Morton Grove Pharmaceuticals, Inc. Terminated
Class II September 6, 2017 Morphine Sulfate Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle… Defective container: Oral solution leaking from container. Tris Pharma Inc. Terminated
Class II August 30, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward… Labeling: Label Mixup; potentially mislabeled C. O. Truxton Terminated
Class I August 30, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward… Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets… C. O. Truxton Terminated
Class I August 30, 2017 CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for… Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and… Brian P. Richardson Terminated
Class I August 30, 2017 Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward… Labeling: Label Mixup; potentially mislabeled C. O. Truxton Terminated
Class II August 30, 2017 Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count… Labeling: Label Mixup; potentially mislabeled C. O. Truxton Terminated
Class II August 30, 2017 Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward… Labeling: Label Mixup; potentially mislabeled C. O. Truxton Terminated
Class II August 30, 2017 Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for:… Labeling: Label Mixup; potentially mislabeled C. O. Truxton Terminated
Class II August 30, 2017 Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic… Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination The Harvard Drug Group Terminated
Class II August 30, 2017 Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL)… Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination The Harvard Drug Group Terminated
Class II August 30, 2017 Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL)… Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination The Harvard Drug Group Terminated
Class II August 30, 2017 Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473… Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination The Harvard Drug Group Terminated
Class II August 30, 2017 Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473… Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination The Harvard Drug Group Terminated
Class III August 30, 2017 Phentermine Hydrochloride Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle (… Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th… PD-Rx Pharmaceuticals, Inc. Terminated
Class I August 23, 2017 Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and… Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the… Lupin Limited (Unit 1) Terminated
Class III August 23, 2017 Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class II August 23, 2017 Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz).,… Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to… Global Marketing Enterprises, Inc. Terminated
Class III August 23, 2017 Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured… Failed impurities/degradation specifications: Out of specification for a related compound C. AVKARE Inc. Terminated
Class III August 23, 2017 Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class I August 23, 2017 Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by:… Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and… DYNAMIC TECHNICAL FORMULATIONS Terminated
Class III August 23, 2017 Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine… Crystallization with subpotent out of specification assay results for chlorhexidine. Akorn Inc Terminated
Class III August 23, 2017 Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%)… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class II August 23, 2017 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira,… Presence of Particulate Matter; stainless steel ICU Medical Inc Terminated
Class III August 23, 2017 Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class I August 23, 2017 ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore… Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. HARDCORE FORMULATIONS Terminated
Class III August 23, 2017 Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine… Crystallization with subpotent out of specification assay results for chlorhexidine. Akorn Inc Terminated
Class I August 23, 2017 GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC,… Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product… Genetic Edge Compounds LLC Terminated
Class III August 23, 2017 Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml… Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. Linde Eckstein Gmbh + Co KG Terminated
Class III August 23, 2017 Phentermine Hydrochloride Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01),… Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities… KVK-Tech, Inc. Terminated
Class III August 23, 2017 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC… Crystallization with subpotent out of specification assay results for chlorhexidine. Akorn Inc Terminated
Class I August 23, 2017 D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations,… Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. HARDCORE FORMULATIONS Terminated
Class II August 23, 2017 Entecavir Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber… Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month… Hetero USA Inc Terminated
Class II August 23, 2017 PROCRIT Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use… Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials. Amgen, Inc. Terminated
Class II August 16, 2017 Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe,… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL)… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL)… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only,… Presence of Foreign Substance: potential presence of plastic particles. X-Gen Pharmaceuticals Inc. Terminated
Class II August 16, 2017 Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe,… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL)… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class II August 16, 2017 Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose… Lack of Sterility Assurance. Cantrell Drug Company Terminated
Class III August 16, 2017 Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose… Failed Moisture Limits: out of specification test results for water content obtained during stability testing. Teva Pharmaceuticals USA Terminated
Class II August 16, 2017 Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road,… GMP Deviations: The firm does not include an SOP for testing for out of specifications. AtHome Medical, Inc. Terminated