Ultra Seal Corporation recalls PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case
Recalled November 3, 2021 · FDA recall D-0070-2022 · Ultra Seal
Hazard
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. · FDA Class III
Units
2,484,274 tablets
Sold at
Nationwide in the USA.
Description
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Product
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
Manufacturer(s)
Ultra Seal Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →