Ultra Seal Corporation recalls AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in
Recalled November 3, 2021 · FDA recall D-0073-2022 · Ultra Seal
Hazard
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. · FDA Class III
Units
1,480,981 tablets
Sold at
Nationwide in the USA.
Description
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Product
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
Manufacturer(s)
Ultra Seal Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →