D-0516-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2019
- Initiation Date
- February 19, 2019
- Termination Date
- December 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 2,413 bottles b) 3,355 bottles
Product Description
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Reason for Recall
Failed dissolution specifications
Distribution Pattern
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
Code Information
Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020