Drug product
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00
D-0498-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,180,000 packets
- Official record key
drug-enforcement:D-0498-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9450, Exp. Date 01/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations