Drug product
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
D-0527-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 917,304 tablets
- Official record key
drug-enforcement:D-0527-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: C121L Bulk Lots: 19G074, 19G075
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations