FDA-Drug2025-09-17Class II
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Sold states
USA Nationwide.
Affected count
N/A
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0624-2025Don't want to check this manually?
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