Class III
Terminated
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
- Company
- Amerigen Pharmaceuticals Inc.
- Recall Initiated
- February 19, 2019
- Posted
- February 27, 2019
- Recall Number
- D-0516-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 2,413 bottles b) 3,355 bottles
- Firm Location
- Lyndhurst, NJ, United States
Reason for Recall
Failed dissolution specifications
Distribution
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
Lot / Code Info
Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
More recalls by Amerigen Pharmaceuticals Inc.
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