FDAJanuary 24, 2022drug

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989

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

The hazard

cGMP deviations

What to do

FDA enforcement status: Terminated

Brands named

ultra sealultra

Recall history

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

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