Ultra Seal Corporation recalls Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactu
Recalled August 26, 2020 · FDA recall D-1513-2020 · Ultra Seal
Hazard
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed. · FDA Class III
Units
701,735 packets
Sold at
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Description
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Product
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,
Manufacturer(s)
Ultra Seal Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →