Product: 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
Reason for recall: Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Recall initiated: 20210921
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated