FDAFDA · Food and drugs·Recall number D-0766-2021
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
Published September 1, 2021 · Recall initiated: August 13, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SigmaPharm Laboratories LLC
- Distributor
- Disttibuted Nationwide in the USA.
- Lot
- Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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