🍔 Food 💊 Drugs 🏥 Medical Devices
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44 Class II

Reason: Presence of foreign substance: plastic-like substance.

MACLEODS PHARMA USA, INC 20240507 Ongoing
Distributed: USA Nationwide
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Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04 Class II

Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Lupin Pharmaceuticals Inc. 20240424 Terminated
Distributed: USA nationwide
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Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04 Class II

Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Lupin Pharmaceuticals Inc. 20240424 Terminated
Distributed: USA nationwide
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Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01 Class II

Reason: cGMP Deviations

Dercher Enterprises, Inc., DBA Gordon Laboratories 20240412 Completed
Distributed: Product was distributed nationwide within the United States
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Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV. Class I

Reason: Marketed Without An Approved NDA/ANDA

Stop Clopez Corp 20240422 Terminated
Distributed: Distribution worldwide via amazon.com
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Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01 Class II

Reason: Out of specification for assay

SUN PHARMACEUTICAL INDUSTRIES INC 20240419 Ongoing
Distributed: Nationwide within the United States
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Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. Class II

Reason: Discoloration: Dotted and yellow spots on tablets

Aurobindo Pharma USA Inc. 20240424 Ongoing
Distributed: Nationwide in the USA
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Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. Class II

Reason: Discoloration: Dotted and yellow spots on tablets

Aurobindo Pharma USA Inc. 20240424 Ongoing
Distributed: Nationwide in the USA
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Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06 Class III

Reason: Subpotent drug

Acella Pharmaceuticals, LLC 20240424 Terminated
Distributed: Nationwide in the US and Puerto Rico.
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TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762 Class II

Reason: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol

RemedyRepack Inc. 20240502 Terminated
Distributed: Nationwide in the USA
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