Drug product
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
D-0344-2019
Product summary
- Event
- Event 81858
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3552 bottles
- Official record key
drug-enforcement:D-0344-2019
Official wording
Reason: Failed Dissolution Specifications
Code information: a) Lot # 18B005 A and b) Lot # 18B005 B, exp 02/2020
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