Drug product
DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
D-0554-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,727,657 tablets
- Official record key
drug-enforcement:D-0554-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: M941L M940LA Bulk Lots: 19C065, 19F081, 19H083, 17D088
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations