Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43...
FDA Recall #D-0344-2019 — Class III — December 20, 2018
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
Recalling Firm
Amerigen Pharmaceuticals Inc. — Lyndhurst, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
3552 bottles
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated