Drug 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)
D-0075-2022
Product summary
- Event
- Event 88843
- Status
- Terminated
- Classification
- Class III
- Quantity
- 991,310 tablets
- Official record key
drug-enforcement:D-0075-2022
Official wording
Reason: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Code information: 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
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out-of-Specification