Drug product
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
D-0553-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,769,495 tablets
- Official record key
drug-enforcement:D-0553-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations