Drug product
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
D-0555-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,464,418 tablets
- Official record key
drug-enforcement:D-0555-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: M945 Bulk Lots: 18J072, 18K030, 18L123, 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, 19H098
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations