D-0391-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 26, 2022
- Initiation Date
- December 6, 2021
- Termination Date
- June 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,639,838 tablets
Product Description
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
Reason for Recall
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Distribution Pattern
Nationwide in the USA
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