Drug product
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
D-0544-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,297,709 tablets
- Official record key
drug-enforcement:D-0544-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: M320L Bulk Lots: 18M063, 19G076
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations