Drug product
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
D-0525-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,798,048 tablets
- Official record key
drug-enforcement:D-0525-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: C111L Bulk Lot: 18L028
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations