Drug product
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
D-0513-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 448,300 packets
- Official record key
drug-enforcement:D-0513-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9859, Exp. Date 10/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations