Home / Recalls / Amerigen Pharmaceuticals Inc. / D-0344-2019

D-0344-2019 Class III Terminated

Recalled by Amerigen Pharmaceuticals Inc. — Lyndhurst, NJ

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
3552 bottles

Product Description

Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ

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

a) Lot # 18B005 A and b) Lot # 18B005 B, exp 02/2020

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-0249-2019 Class III — Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b (October 5, 2018)