Drug product
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
D-0551-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,477,641 tablets
- Official record key
drug-enforcement:D-0551-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: M740LA Bulk Lots: 19C022, 19C023
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations