Drug product
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11
D-0854-2020
Product summary
- Event
- Event 84898
- Status
- Terminated
- Classification
- Class II
- Quantity
- 973 cartons
- Official record key
drug-enforcement:D-0854-2020
Official wording
Reason: Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Code information: Lot #:180276A, Exp date 02/29/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
out of specification