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FDASeptember 21, 2021drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

sigmapharm laboratoriessigmapharm

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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