FDA-Drug2025-09-10Class II
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Amneal Pharmaceuticals, LLC
Hazard
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Sold states
Distributed Nationwide in the USA
Affected count
3,363 100-count bottles
Manufactured in
400 Crossing Blvd Fl 3, N/A, Bridgewater, NJ, United States
Products
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0619-2025Don't want to check this manually?
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