SigmaPharm Laboratories LLC is recalling 1,192 bottles of Sodium Phenylbutyrate Powder (250 grams) because routine testing discovered impurity results that are outside of required safety specifications. This prescription medication is used to treat urea cycle disorders and is packaged in 500 cc white bottles with child-resistant caps. Consumers should check their medicine cabinet for the specific lot numbers and expiration dates affected by this nationwide recall.
The product contains impurities or degradation levels that exceed approved safety limits, which could potentially affect the medication's purity or effectiveness over time.
Pharmacist consultation and refund
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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