FDA-Drug2021-11-03Class III
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (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
42,394,018 tablets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2022Don't want to check this manually?
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