Drug product
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
D-0466-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 226,390 packets
- Official record key
drug-enforcement:D-0466-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9565, Exp. Date 04/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations