Drug product
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
D-0992-2022
Product summary
- Event
- Event 90182
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4224 cartons
- Official record key
drug-enforcement:D-0992-2022
Official wording
Reason: Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Code information: Lot # GD01090, Exp 05/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-Of-Specification