D-0345-2019 Class III Terminated
FDA drug recall D-0345-2019 was initiated by Amerigen Pharmaceuticals Inc. on December 20, 2018 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated December 17, 2019). Affected quantity: 771 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 2, 2019
- Initiation Date
- December 20, 2018
- Termination Date
- December 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 771 bottles
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
Code Information
Lot # 18E031, exp 05/2020