🍔 Food 💊 Drugs 🏥 Medical Devices
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30 Class II

Reason: Failed Dissolution Specifications

Glenmark Pharmaceuticals Inc., USA 20231020 Ongoing
Distributed: USA nationwide
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Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11 Class III

Reason: Sub-potent Drug: Lower potency than labeled.

Zyla Life Sciences US Inc. 20231020 Ongoing
Distributed: Nationwide
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Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08. Class III

Reason: Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

VistaPharm LLC 20231026 Terminated
Distributed: Nationwide and Saudi Arabia
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Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60. Class II

Reason: Failed Dissolution Specifications: Out of specification for dissolution.

Glenmark Pharmaceuticals Inc., USA 20231023 Ongoing
Distributed: Nationwide
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Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79 Class II

Reason: CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.

MEDLINE INDUSTRIES, LP - Northfield 20231004 Terminated
Distributed: Nationwide
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Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10 Class II

Reason: Failed Dissolution Specifications

Amneal Pharmaceuticals of New York, LLC 20231027 Terminated
Distributed: Nationwide in the USA and Puerto Rico
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Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1 Class III

Reason: Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Taro Pharmaceuticals Inc. 20231106 Terminated
Distributed: Nationwide in the USA
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Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11 Class III

Reason: Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

AbbVie Inc. 20231017 Ongoing
Distributed: Distributed in the US. No government or foreign consignees.
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Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05 Class II

Reason: Crystallization; identified as Buprenorphine free base

PAR Sterile Products LLC 20211109 Terminated
Distributed: Nationwide USA
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Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10. Class II

Reason: Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

Dr. Reddy's Laboratories, Inc. 20231013 Terminated
Distributed: Nationwide
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