FDA-Drug2020-08-26Class III
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,
Ultra Seal Corporation
Hazard
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Sold states
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Affected count
701,735 packets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1513-2020Don't want to check this manually?
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