Drug product
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
D-0107-2018
Product summary
- Event
- Event 78502
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1264 bottles
- Official record key
drug-enforcement:D-0107-2018
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: P0910-017, Exp. 05/2019
Distribution pattern: NY only
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications