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FDAAugust 13, 2021drug

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4

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

The hazard

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

What to do

FDA enforcement status: Terminated

Brands named

sigmapharm laboratoriessigmapharm

UPCs

342794086144

Recall history

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

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Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4 — Recall Details · AllClear