Drug product
Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
D-0345-2019
Product summary
- Event
- Event 81858
- Status
- Terminated
- Classification
- Class III
- Quantity
- 771 bottles
- Official record key
drug-enforcement:D-0345-2019
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # 18E031, exp 05/2020
Distribution pattern: Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications