FDA-Drug2021-11-03Class III
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 )
Ultra Seal Corporation
Hazard
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Sold states
Nationwide in the USA.
Affected count
1,480,981 tablets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
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 )
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0073-2022Don't want to check this manually?
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