Home / Recalls / Amerigen Pharmaceuticals Inc. / D-0249-2019

D-0249-2019 Class III Terminated

Recalled by Amerigen Pharmaceuticals Inc. — Lyndhurst, NJ

Recall Details

Product Type
Drugs
Report Date
October 24, 2018
Initiation Date
October 5, 2018
Termination Date
September 30, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,232 bottles: a) 4,146 bottles; b) 1,086 bottles

Product Description

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.

Reason for Recall

Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.

Distribution Pattern

Product was distributed U.S. nationwide.

Code Information

Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19

Other recalls by Amerigen Pharmaceuticals Inc.

  • D-0516-2019 Class III — Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) (February 19, 2019)
  • D-0345-2019 Class III — Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: (December 20, 2018)
  • D-0344-2019 Class III — Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) (December 20, 2018)