Drug product
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832
D-0482-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,107,565 packets
- Official record key
drug-enforcement:D-0482-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: K9770, AK9770 Exp. Date 08/2022; AK9958, K9958 Exp. Date 12/2022; AK9717, Exp. Date 07/2022; AK9522, AK9641 , Exp. Date 03/2022; AK9817, Exp. Date 09/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations