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…

Recall date

September 21, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0898-2021

FDA classification

Class II

Brand / firm

SigmaPharm Laboratories LLC

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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