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
Recall Number: D-0766-2021
Firm: SigmaPharm Laboratories LLC
Classification: Class II
Status: Terminated
Report Date: 20210901
Initiation Date: 20210813
Termination Date: 20220926
Reason for Recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Product Description
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