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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 July 8, 2015 TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 mL Bags, Rx… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assure Lincare, Inc. Terminated
Class II July 8, 2015 Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 50 mL Bags, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg,… Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the… Takeda Pharmaceuticals North America, Inc. Terminated
Class II July 8, 2015 VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin 750 mg/NS 100 ml accuflo, Packaged in 100 mL Bags, Rx Only. Compounded by:… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 6 150 mL Bags, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, Qty: 1 500 mL Bag, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Compounded by:… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 FLUOROURACIL 1560MG / D5W 281ML, Qty: 1 281 mL Bag, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by… Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg… The Harvard Drug Group, LLC Terminated
Class III July 1, 2015 Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen,… Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were… Actavis Inc Terminated
Class III July 1, 2015 E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx… Failed stability specifications:This recall has been initiated due to out of specification results for viscosity. Bracco Diagnostic Inc Terminated
Class III July 1, 2015 Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains… Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient… Indiana Botanic Gardens, Inc Terminated
Class III June 24, 2015 Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III June 24, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules… Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during… Novartis Pharmaceuticals Corp. Terminated
Class II June 24, 2015 Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only,… Failed dissolution specifications American Health Packaging Terminated
Class II June 24, 2015 Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a)… CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints. Allegiant Health Terminated
Class III June 24, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules… Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during… Novartis Pharmaceuticals Corp. Terminated
Class II June 24, 2015 NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx… Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle… AstraZeneca Pharmaceuticals LP Terminated
Class III June 24, 2015 Fentanyl Citrate Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV… Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). West-Ward Pharmaceutical Corp. Terminated
Class III June 24, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only… Subpotent drug Dr. Reddy's Laboratories, Inc. Terminated
Class II June 24, 2015 Divalproex sodium Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd.… Failed Dissolution Specifications; exceeded specification at the 9 hour time point Dr. Reddy's Laboratories, Inc. Terminated
Class II June 24, 2015 Divalproex sodium Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100… Failed Dissolution Specifications; exceeded specification at the 9 hour time point Dr. Reddy's Laboratories, Inc. Terminated
Class III June 24, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count… Subpotent drug Dr. Reddy's Laboratories, Inc. Terminated
Class III June 24, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count… Subpotent drug Dr. Reddy's Laboratories, Inc. Terminated
Class III June 24, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count… Subpotent drug Dr. Reddy's Laboratories, Inc. Terminated
Class II June 17, 2015 Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only,… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per… Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than… SCA Pharmaceuticals Terminated
Class II June 17, 2015 Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only,… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx… Failed Impurities/Degradation Specifications Akorn, Inc. Terminated
Class II June 17, 2015 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only,… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37%… Labeling: incorrect or missing lot number and/or expiration date Mallinckrodt, Inc. Terminated
Class II June 17, 2015 Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx… Failed Impurities/Degradation Specifications Akorn, Inc. Terminated
Class II June 17, 2015 Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only.… Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point. Valeant Pharmaceuticals North America LLC Terminated
Class II June 17, 2015 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only,… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by… Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Montana Compounding Pharmacy Terminated
Class II June 17, 2015 HEPARIN SODIUM IN SODIUM CHLORIDE Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a… Subpotent Drug; out of specification results for heparin raw material Baxter Healthcare Corp Terminated
Class III June 10, 2015 Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and… Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21… Sandoz, Inc Terminated
Class II June 10, 2015 SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight… Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was… Medtech Products, Inc. Terminated
Class II June 10, 2015 Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for… Failed Dissolution Specifications: OOS result during stability testing Teva Pharmaceuticals USA Terminated
Class II June 10, 2015 Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan… Failed Dissolution Specifications: Low out of specification dissolution results. Mylan Lab Inc Terminated
Class II June 10, 2015 KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and… Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids Fresenius Kabi USA, LLC Terminated
Class II June 3, 2015 SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC,… cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited,… Blenheim Pharmacal, Inc. Terminated
Class II June 3, 2015 HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class III June 3, 2015 QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral… Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability… Teva Pharmaceuticals USA Terminated
Class I June 3, 2015 LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured… Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary… Hospira Inc. Terminated
Class II June 3, 2015 HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy,… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC,… cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited,… Blenheim Pharmacal, Inc. Terminated
Class II June 3, 2015 GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy,… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class I June 3, 2015 Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot#… Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled… Stroheckers Inc Pharmacy Terminated
Class II June 3, 2015 ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced… Lack of Assurance of Sterility Advanced Physician Solutions, Inc. Terminated
Class II June 3, 2015 Acarbose Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles,… Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9… Boehringer Ingelheim Roxane Inc Completed
Class II June 3, 2015 Daytrana Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr),… Defective Delivery System: One lot exceeded the mechanical peel specification Noven Pharmaceuticals, Inc. Terminated
Class III May 27, 2015 Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100… Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class III May 27, 2015 ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz… Failed pH specification Oasis Medical, Inc. Terminated
Class II May 20, 2015 Naltrexone 4.5 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Progest 200 mg/1 mL Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 DNCB 0.3% Ointment, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 BLT New Formula 20%/7%/7% Sample, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Hydroxyurea 100 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Fortifed Tobramycin 15 mg/1 mL Opth., Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 T4 66mcg - T3 10mcg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Methenamine/Phenyl Salicylate Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Lansoprazole 3 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Methylcobalamin 1000 mcg/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Verapamil HCl 15% Topical Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE… Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Akorn, Inc. Terminated
Class II May 20, 2015 Acetylcysteine 10% Opth Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Ciprodex with Amphoteracin B (ear drops), Health Innov Pharmacy, 295 Pinehurst Ave,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Carvedilol 1.25 mg/mL, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class III May 20, 2015 Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03),… Subpotent drug Apotex Inc. Terminated
Class II May 20, 2015 Fortified Vancomycin 25 mg/1 mL Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Nexium 2 mg/1 mL Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Glycerin 98.5% Opth. Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Pregnenolone 20 mg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Phospholine Iodide 0.03% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst Ave,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Estradiol 0.01% Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Hydroquinone 10% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Leucovorin 1 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Nifedipine 0.2% - Lidocaine 2% Jelly, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Folic Acid 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy,… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Sildenafil 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Estriol 5% Cream Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class III May 20, 2015 Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured… Subpotent drug Apotex Inc. Terminated
Class II May 20, 2015 Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Pyrimethamine 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Renacidin Irrigation Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Cyanocobalamin 2000mcg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Cyclandelate 200 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Nitroglycerin 0.2% Compd Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C.,… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Nadolol 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Hydrocortisone 1.6 mg/0.5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and… Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. Mission Pharmacal Co Terminated
Class II May 20, 2015 Pyridoxine 100 mg/1 mL Syrup, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Boric Acid Vaginal Capsules, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 HCG 1000 Units/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Thymol 2% Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Nortriptyline 10 mg/5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Spironolactone 5 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Keto 10%-Gabap 10%-Ketamine 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Serum 50% BSS 50% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class III May 20, 2015 Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03),… Subpotent drug Apotex Inc. Terminated
Class II May 20, 2015 Glycopyrrolate 0.2 mg/1 mL Susp (Robinul), Health Innov Pharmacy, 295 Pinehurst Ave,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Promethazine 25 mg/0.5 mLGel, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY… Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Akorn, Inc. Terminated
Class II May 20, 2015 Warfarin 2.5 ng Lactose Free Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Coconut Oil Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Voriconazole 1% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Laureth-P 1% Injection (Polidocanol), Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Phen 15 mg - Topri 92 mg SR Cap (Qsymia), Health Innov Pharmacy, 295 Pinehurst Ave,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE 25 mcg/10… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Triest 5 mg - Progest 150 mg Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Baclofen 20 mg/4 mL Susp., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Rifampin 25 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Levodopa 250 mg NSR Capsules,Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave, Southern… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL,… Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C. Terminated
Class II May 20, 2015 Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister… Subpotent Drug Janssen Pharmaceuticals, Inc. Terminated
Class II May 20, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE… Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Akorn, Inc. Terminated
Class II May 20, 2015 Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad… Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. Mission Pharmacal Co Terminated
Class II May 20, 2015 EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387,… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated… Health Innovations Pharmacy, Inc Terminated
Class II May 20, 2015 Nitrofurantoin Monohydrate/ Macrocrystalline NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only ---… Failed Dissolution Specification; 6 month time point Alvogen, Inc Terminated
Class III May 20, 2015 MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM… Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal… Medtech Products, Inc. Terminated
Class III May 20, 2015 Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured… Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Cipla Limited Terminated
Class I May 20, 2015 magnesium sulfate in dextrose MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira,… Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the… Hospira Inc. Terminated
Class I May 13, 2015 iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W,… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an… Detox Transforms Terminated
Class I May 13, 2015 EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature,… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making… Detox Transforms Terminated
Class II May 13, 2015 KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber… Crystallization RemedyRepack Inc. Terminated
Class I May 13, 2015 Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only,… Non-Sterility: The recalled lot failed sterility testing. Physician Preferred Medical, LLC Terminated
Class I May 13, 2015 BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an… Detox Transforms Terminated
Class I May 13, 2015 AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W,… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an… Detox Transforms Terminated
Class I May 13, 2015 iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making… Detox Transforms Terminated
Class II May 13, 2015 C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC… Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL Cody Laboratories, Inc. Terminated
Class I May 13, 2015 M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone)… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic… Anabolic Science Labs, LLC Terminated
Class II May 13, 2015 Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000… Failed Tablet/Capsule Specifications: out of specification for thickness. Wockhardt Usa Inc. Terminated
Class I May 13, 2015 HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg),… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic… Anabolic Science Labs, LLC Terminated
Class I May 13, 2015 M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14D 20 mg),… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic… Anabolic Science Labs, LLC Terminated
Class I May 13, 2015 Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place,… Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein REFA Enterprises, LLC Terminated
Class I May 13, 2015 PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg:… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic… Anabolic Science Labs, LLC Terminated
Class II May 13, 2015 Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only,… Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity Romark Laboratories, L.C. Terminated
Class I May 13, 2015 Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Commonwealth… Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein REFA Enterprises, LLC Terminated
Class I May 13, 2015 ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen… Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine… Ultra ZX Supplements Terminated
Class I May 13, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc.,… Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. Hospira Inc. Terminated
Class I May 13, 2015 ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg,… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic… Anabolic Science Labs, LLC Terminated
Class I May 13, 2015 SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg,… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic… Anabolic Science Labs, LLC Terminated
Class I May 13, 2015 7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic… Anabolic Science Labs, LLC Terminated
Class II May 6, 2015 Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only,… Crystallization Hospira Inc. Terminated
Class II May 6, 2015 Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only,… Crystallization Hospira Inc. Terminated
Class II May 6, 2015 Fluoxetine Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and… Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that… Teva Pharmaceuticals USA Terminated
Class II May 6, 2015 Fluoxetine Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva… Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that… Teva Pharmaceuticals USA Terminated
Class II April 29, 2015 Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL) Products failed the Antimicrobial Effectiveness Test Tarmac Products, Inc. Terminated
Class III April 29, 2015 Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually… Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including… Nomax Inc Terminated
Class II April 29, 2015 Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle Products failed the Antimicrobial Effectiveness Test Tarmac Products, Inc. Terminated
Class II April 29, 2015 Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged… Presence of particulate. SCA Pharmaceuticals Terminated
Class II April 29, 2015 Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 mL) bottle Products failed the Antimicrobial Effectiveness Test. Tarmac Products, Inc. Terminated
Class I April 29, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL,… Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the… Hospira Inc. Terminated
Class III April 29, 2015 Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein… Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including… Nomax Inc Terminated
Class III April 29, 2015 Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO,… Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including… Nomax Inc Terminated
Class II April 29, 2015 Ethinyl Estradiol active pharmaceutical ingredient packaged in varying grams or kg in… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Uridine-5'Triphosphate Trisodium Salt active pharmaceutical ingredient packaged in… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Acetazolamide active pharmaceutical ingredient packaged in varying grams or kg in bags or… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Histamine Diphosphate active pharmaceutical ingredient packaged in varying grams or kg in… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Chloroquine Phosphate active pharmaceutical ingredient packaged in varying grams or kg in… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Potassium Phosphate Monobasic pharmaceutical ingredient packaged in varying grams or kg… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Cabergoline active pharmaceutical ingredient packaged in varying grams or kg in bags or… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Chloramphenicol active pharmaceutical ingredient packaged in varying grams or kg in bags… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Montelukast Sodium active pharmaceutical ingredient packaged in varying grams or kg in… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Tranilast active pharmaceutical ingredient packaged in varying grams or kg in bags or… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Guanabenz Acetate active pharmaceutical ingredient packaged in varying grams or kg in… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Doxycycline HCI active pharmaceutical ingredient packaged in varying grams or kg in bags… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Norethindrone Acetate active pharmaceutical ingredient packaged in varying grams or kg in… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Zinc Pyrithione active pharmaceutical ingredient packaged in varying grams or kg in bags… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Cephalexin Monohydrate active pharmaceutical ingredient packaged in varying grams or kg… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Tadalafil Citrate active pharmaceutical ingredient packaged in varying grams or kg in… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Adenosine active pharmaceutical ingredient packaged in varying grams or kg in bags or… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Cephalexin active pharmaceutical ingredient packaged in varying grams or kg in bags or… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Methocarbamol active pharmaceutical ingredient packaged in varying grams or kg in bags or… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Metaxalone active pharmaceutical ingredient packaged in varying grams or kg in bags or… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Levalbuterol HCl active pharmaceutical ingredient packaged in varying grams or kg in bags… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated
Class II April 29, 2015 Aldosterone active pharmaceutical ingredient packaged in varying grams or kg in bags or… Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are… Attix Pharmaceuticals Terminated