SigmaPharm recalls specific batches of Sodium Phenylbutyrate powder (Rx only) due to failed impurities testing. Affected lots expire May 2023-Nov 2023. Consumers should contact the manufacturer for details.
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
SigmaPharm is recalling certain batches of Sodium Phenylbutyrate powder (250g) that failed impurities testing during routine quality checks. This could pose health risks if the impurities are harmful, though the exact risk isn't specified in the recall notice.
The product failed routine impurities testing, meaning it contains substances not supposed to be present. These impurities could potentially cause health issues, but the recall doesn't specify the exact risk or how serious it is.
People with prescriptions for Sodium Phenylbutyrate powder from SigmaPharm Laboratories LLC in Bensalem, PA. Those using the product as directed for medical purposes are most at risk.
Check for the product name 'Sodium Phenylbutyrate Powder', 250 grams, Rx only. Look for lot numbers 1813001-1906701 and expiration dates May 2023 through May 2024.
Identify the lot number and expiration date on the product label to confirm if it's affected.
The recall states the product failed impurities testing, but does not specify if it's safe to use. Consumers should not use affected batches.
Check for lot numbers 1813001-1906701 and expiration dates from May 2023 through May 2024 on the product label.
The recall does not specify a remedy, so contact SigmaPharm Laboratories LLC directly for instructions.
We’ve drafted a message you can send SigmaPharm to request your refund or repair — edit it as you like.
Subject: Recall D-0766-2021 — SigmaPharm SigmaPharm Hello, I own a SigmaPharm that is covered by recall D-0766-2021 from SigmaPharm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
