🍔 Food 💊 Drugs 🏥 Medical Devices
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05 Class II

Reason: Lack of Assurance of Sterility: Malformed crimped collar seal

Sanofi-Aventis U.S. LLC 20230411 Ongoing
Distributed: Nationwide in the USA
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Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724. Class II

Reason: Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

Hikma Pharmaceuticals USA Inc. 20230511 Terminated
Distributed: Nationwide in the USA and Puerto Rico
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Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61 Class III

Reason: Product mixup: one foreign tablet found in product.

The Harvard Drug Group 20230424 Terminated
Distributed: USA Nationwide
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Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6 Class II

Reason: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.

Apotex Corp. 20230426 Completed
Distributed: Nationwide throughout the United States
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Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21. Class I

Reason: Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

Camber Pharmaceuticals Inc. 20230313 Ongoing
Distributed: Nationwide in the USA
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DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7. Class I

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Gadget Island, Inc 20230426 Ongoing
Distributed: Nationwide in the USA.
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NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3. Class I

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Gadget Island, Inc 20230426 Ongoing
Distributed: Nationwide in the USA.
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Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0. Class I

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Gadget Island, Inc 20230426 Ongoing
Distributed: Nationwide in the USA.
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Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles. Class II

Reason: CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. 20230331 Ongoing
Distributed: Nationwide within the United States
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Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles Class II

Reason: CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. 20230331 Ongoing
Distributed: Nationwide within the United States
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