SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-1
Recalled September 1, 2021 · FDA recall D-0766-2021 · SigmaPharm Laboratories
Hazard
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing. · FDA Class II
Units
1,993 bottles
Sold at
Disttibuted Nationwide in the USA.
Description
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
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
Manufacturer(s)
SigmaPharm Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →