Drug product
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24
D-0473-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 301,842 bottles
- Official record key
drug-enforcement:D-0473-2022
Official wording
Reason: cGMP deviations
Code information: Lot#: 18M063, Exp. Date 01/2022; 19G076, Exp. Date 09/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations