Class III
Terminated
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.
- Company
- Amerigen Pharmaceuticals Inc.
- Recall Initiated
- October 5, 2018
- Posted
- October 24, 2018
- Recall Number
- D-0249-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
- Firm Location
- Lyndhurst, NJ, United States
Reason for Recall
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Distribution
Product was distributed U.S. nationwide.
Lot / Code Info
Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19
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