Ascend Laboratories, LLC is recalling 71,244 sachets of Fosfomycin Tromethamine Granules for Oral Solution (3 grams), a prescription antibiotic used to treat urinary tract infections. This recall was initiated after testing revealed that the medication exceeded allowed limits for organic impurities, which can occur as the drug degrades over time. If you have been prescribed this medication, you should consult your pharmacist or healthcare provider to determine if your specific supply is affected.
The medication contains organic impurities that are outside of established safety and quality specifications. While no specific injuries have been reported, impurities and degradation products can potentially reduce the drug's effectiveness or cause unexpected side effects.
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Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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