Drug product
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
D-0249-2019
Product summary
- Event
- Event 81189
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
- Official record key
drug-enforcement:D-0249-2019
Official wording
Reason: Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Code information: Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19
Distribution pattern: Product was distributed U.S. nationwide.
Derived failure modes
-
Potency or specification failure
Out-of-Specification