FDA recall D-0625-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class II · drug

Product

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).

Reason for recall

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.

Distribution

USA Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-09-02
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0625-2025