Drug product
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
D-0495-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 447,050 packets
- Official record key
drug-enforcement:D-0495-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9478, Exp. Date 02/2022; AK9799, Exp. Date 09/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations