FDAOctober 13, 2021drug

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )

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

The hazard

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

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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