Class II · Moderate riskTerminated Initiated Apr 13, 2022 (4 years ago)
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Temperature abuse
What was recalled
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
NDC code
0904-2725-61
Origin
VA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1059-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesNDC 55154-7895-0D-0625-2025
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesNDC 0904-2725-61D-0624-2025
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…