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.
Recall initiated: 20210813
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated