FDA-Drug2020-08-26Class III
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Ultra Seal Corporation
Hazard
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Sold states
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Affected count
4,666,355 packets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1512-2020Don't want to check this manually?
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