PlainRecalls
FDA Drug Low Class III Terminated

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)

Reported: November 3, 2021 Initiated: October 13, 2021 #D-0075-2022

Product Description

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)

Reason for Recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Details

Recalling Firm
Ultra Seal Corporation
Units Affected
991,310 tablets
Distribution
Nationwide in the USA.
Location
New Paltz, NY

Frequently Asked Questions

What product was recalled?
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). Recalled by Ultra Seal Corporation. Units affected: 991,310 tablets.
Why was this product recalled?
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 3, 2021. Severity: Low. Recall number: D-0075-2022.