Drug product
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
D-0518-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 447,190 packets
- Official record key
drug-enforcement:D-0518-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9651, Exp. Date 06/2022; AK9437, Exp. Date 01/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations