🍔 Food 💊 Drugs 🏥 Medical Devices
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Class II

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

Golden State Medical Supply Inc. 20240513 Terminated
Distributed: Nationwide in the U.S.
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Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01 Class II

Reason: Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C

PACIRA PHARMACEUTICALS INC 20240612 Ongoing
Distributed: US Nationwide.
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Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606 Class II

Reason: Discoloration: Brownish tablets

Contract Pharmacal Corporation 20240520 Ongoing
Distributed: MI
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Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24 Class II

Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Pfizer Inc. 20240520 Ongoing
Distributed: US Nationwide and Puerto Rico.
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Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03 Class II

Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Pfizer Inc. 20240520 Ongoing
Distributed: US Nationwide and Puerto Rico.
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Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024. Class II

Reason: Presence of Foreign Substance; Broken metal piece found embedded in tablet.

Coast Quality Pharmacy, LLC dba Anazao Health 20240424 Completed
Distributed: U.S. Nationwide
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Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90 Class II

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Breckenridge Pharmaceutical, Inc 20240517 Terminated
Distributed: Nationwide in the USA
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Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34 Class II

Reason: Subpotent Drug

Teva Pharmaceuticals USA, Inc 20240604 Ongoing
Distributed: Nationwide within the United States
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Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0 Class II

Reason: Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile

Consumer Product Partners, LLC 20240528 Terminated
Distributed: Nationwide.
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Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03 Class II

Reason: Failed Content Uniformity Specifications

Lupin Pharmaceuticals Inc. 20240530 Terminated
Distributed: Nationwide in the US
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