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

FDA recall notice · announced September 1, 2021 · Sigmapharm Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Notes

Distribution: Disttibuted Nationwide in the USA.
Lot/code information: Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
Quantity: 1,993 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0766-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.