Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14

Recall Number: D-0898-2021

Firm: SigmaPharm Laboratories LLC

Classification: Class II

Status: Terminated

Report Date: 20211006

Initiation Date: 20210921

Termination Date: 20220926

Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.

Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14