FDAAugust 3, 2020drug

Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,

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

The hazard

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

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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