Drug product
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
D-0391-2022
Product summary
- Firm
- Medique Products
- Event
- Event 89356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,639,838 tablets
- Official record key
drug-enforcement:D-0391-2022
Official wording
Reason: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Code information: Lots: 6492 Exp. 06/2022; 6701 Exp. 10/2022; 6750 Exp. 12/2022; 6853 Exp. 01/2023; 6854 Exp. 01/2023; 6869 Exp. 02/2023; 6898 Exp. 02/2023; 6901 Exp. 02/2023; 7059 Exp. 05/2023; 7060 Exp. 05/2023; 7064 Exp. 06/2023; 7065 Exp. 06/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations