Ultra Seal Corporation recalls Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufac

Recalled August 26, 2020 · FDA recall D-1512-2020 · Ultra Seal

Hazard

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

Units

4,666,355 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

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007

Manufacturer(s)

Ultra Seal Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →