Drug product
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
D-0464-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,508,200 packets
- Official record key
drug-enforcement:D-0464-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9491, AK9496, Exp. Date 02/2022; K9817, Exp. Date 09/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations