Drug product
COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
D-0487-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 226,400 packets
- Official record key
drug-enforcement:D-0487-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9587, Exp. Date 02/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations