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FDAApril 19, 2021drug

Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10

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

The hazard

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

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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