SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-…
- Recall date
- August 13, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0766-2021
- FDA classification
- Class II
- Brand / firm
- SigmaPharm Laboratories LLC
- Sold / distributed
- Disttibuted Nationwide in the USA.
Why it was recalled
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
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