Drug product
RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
D-0914-2018
Product summary
- Event
- Event 79367
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,192 cartons (1,719,200 tablets)
- Official record key
drug-enforcement:D-0914-2018
Official wording
Reason: Failed Stability Specifications
Code information: Lots: 0113064 Exp. 03/2018, 0114628 Exp. 08/2018, 0115189 Exp. 08/2018, 0115462 Exp. 09/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications