🍔 Food 💊 Drugs 🏥 Medical Devices
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06. Class II

Reason: CGMP Deviations: Stability data does not support expiry date.

Private Label Partners, Inc. 20231213 Ongoing
Distributed: NJ
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TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611. Class I

Reason: Chemical Contamination; presence of benzene.

Insight Pharmaceuticals Corporation 20231122 Completed
Distributed: Nationwide and Puerto Rico
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Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88 Class II

Reason: Failed Impurities/Degradation Specifications

SUN PHARMACEUTICAL INDUSTRIES INC 20231204 Terminated
Distributed: Nationwide
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Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66 Class III

Reason: Failed Dissolution Specifications

Siegfried Barbera, SL 20231120 Completed
Distributed: Nationwide
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Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01 Class II

Reason: Failed Dissolution Specifications

Lupin Pharmaceuticals Inc. 20231122 Terminated
Distributed: Product was distributed to 3 wholesale/distributor accounts.
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ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26, Class II

Reason: STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.

STAQ Pharma, Inc. 20231129 Completed
Distributed: Nationwide within the United States
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Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25 Class II

Reason: Failed pH Specifications

Baxter Healthcare Corporation 20231114 Completed
Distributed: Nationwide in the USA
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SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22 Class I

Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Novartis Pharmaceuticals Corporation 20231122 Ongoing
Distributed: Nationwide within the United States
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KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698. Class II

Reason: Failed Impurities/Degradation Specifications

KINDER FARMS LLC 20231113 Ongoing
Distributed: Nationwide
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KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728. Class II

Reason: Failed Impurities/Degradation Specifications

KINDER FARMS LLC 20231113 Ongoing
Distributed: Nationwide
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