Drug product
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
D-1862-2019
Product summary
- Event
- Event 83733
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2472 bottles
- Official record key
drug-enforcement:D-1862-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Code information: Lot #: BFE2E003, Exp 08/31/2020
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out Of Specification