FDA-Drug2021-11-03Class III
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (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
991,310 tablets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2022Don't want to check this manually?
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