SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton
Recalled October 6, 2021 · FDA recall D-0898-2021 · SigmaPharm Laboratories
Hazard
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing. · FDA Class II
Units
1192 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
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
Manufacturer(s)
SigmaPharm Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →