Recalls / Class III
Class IIID-0075-2022
Product
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)
- Affected lot / code info
- Lot #: AK-9457, exp. date 22-Jan; AK-9521, exp. date 22-Mar; AK-9959, exp. date 22-Dec; AK-1017, exp. date 23-Jan
Why it was recalled
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Recalling firm
- Firm
- Ultra Seal Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 521 Main St, N/A, New Paltz, New York 12561-1609
Distribution
- Quantity
- 991,310 tablets
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2021-10-13
- FDA classified
- 2021-10-26
- Posted by FDA
- 2021-11-03
- Terminated
- 2022-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0075-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.