🍔 Food 💊 Drugs 🏥 Medical Devices
Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15 Class II

Reason: Subpotent Drug

Actavis Inc 20150212 Terminated
Distributed: Nationwide
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Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16. Class II

Reason: Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.

Akorn, Inc. 20150227 Terminated
Distributed: Nationwide and Puerto Rico
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Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01 Class III

Reason: Failed Impurities/Degradation Specifications

Pfizer Inc. 20150226 Terminated
Distributed: Nationwide
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Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01 Class III

Reason: Failed Impurities/Degradation Specifications

Pfizer Inc. 20150226 Terminated
Distributed: Nationwide
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Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15 Class III

Reason: Subpotent Drug

AVKARE Inc. 20150227 Terminated
Distributed: Nationwide
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Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15 Class III

Reason: Subpotent Drug

AVKARE Inc. 20150227 Terminated
Distributed: Nationwide
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Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder, Net: 22 kg, Packaged in double plastic liners in a single fiber carton, For manufacturing, processing, or repackaging. Nano Technologies Corporation 1319 Marquettte Drive, Romeoville, IL 60446. NDC 10117-3004 Class III

Reason: Labeling: Illegible label. Writing is rubbing off of labels.

Nanophase Technologies Corporation 20150212 Terminated
Distributed: NJ
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Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10 Class II

Reason: Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

Sagent Pharmaceuticals Inc 20150223 Terminated
Distributed: Nationwide and Puerto Rico
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Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05 Class II

Reason: Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

Sagent Pharmaceuticals Inc 20150223 Terminated
Distributed: Nationwide and Puerto Rico
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AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 Class II

Reason: Failed tablet specifications: One lot was found to contain oversized tablets.

Qualitest Pharmaceuticals 20150213 Terminated
Distributed: Nationwide
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