Drug product
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
D-0484-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,741,384 packets
- Official record key
drug-enforcement:D-0484-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: 9445, AK9445, K9445, Exp. Date 01/2022; K9486, Exp. Date 02/2022; AK9708, Exp. Date 07/2022; AK9515, Exp. Date 03/2022; K9810, Exp. Date 09/2022; AK9658, Exp. Date 06/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations