WhichRecall
Class IIReported 2025-09-17

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).

Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

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No micro-organism was detected on any tablets.

Recall Number
D-0625-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-09-02
Reported
2025-09-17
Distribution
USA Nationwide.
Code Info
Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 03/31/2027
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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