🍔 Food 💊 Drugs 🏥 Medical Devices
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 Class II

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product

Bestco LLC 20240119 Terminated
Distributed: Nationwide in the US
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Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6 Class II

Reason: Failed Impurities/Degradation Specifications: Out-of-specification test results.

Amneal Pharmaceuticals of New York, LLC 20240213 Terminated
Distributed: Nationwide in the USA
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Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1 Class II

Reason: CGMP Deviations: potential presence of Burkholderia cepacia complex

Apotex Corp. 20240209 Ongoing
Distributed: Nationwide in the USA
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Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1. Class II

Reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

IntegraDose Compounding Services LLC 20240122 Ongoing
Distributed: MN
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HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61 Class II

Reason: an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 20240209 Terminated
Distributed: The product was distributed nationwide within the United States.
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Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58 Class III

Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Teva Pharmaceuticals USA, Inc 20240125 Ongoing
Distributed: nationwide
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Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67 Class III

Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Teva Pharmaceuticals USA, Inc 20240125 Ongoing
Distributed: nationwide
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HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11 Class III

Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

Amerisource Health Services LLC 20240201 Terminated
Distributed: Nationwide in the USA
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Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01 Class II

Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

Amneal Pharmaceuticals of New York, LLC 20240115 Terminated
Distributed: USA nationwide.
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Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41 Class II

Reason: CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

NATCO Pharma Limited 20240201 Terminated
Distributed: Nationwide in the USA
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