The Harvard Drug Group LLC (dba Major Pharmaceuticals and Rugby Laboratories) is recalling certain lots of Sulfamethoxazole and Trimethoprim (800 mg/160 mg) Double Strength tablets because a micro-organism was found on the polyester coil used in the product's packaging. While no micro-organisms were detected on the actual tablets, the company is voluntarily recalling these products as a precaution. These prescription antibiotic medications were distributed nationwide in the United States.
A foreign substance (micro-organism) was detected on the packaging material (auxiliary polyester coil) during manufacturing. While the tablets themselves tested negative for contamination, the presence of micro-organisms in the packaging poses a potential risk of product contamination that could affect patient safety.
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Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA
Distributed by Cardinal Health, Dublin, OH 43017. Outer Bag NDC 55154-7895-0 contains Inner blisters NDC 0904-2725-61.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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