Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceu...
FDA Recall #D-0345-2019 — Class III — December 20, 2018
Product Description
Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
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
771 bottles
Distribution
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
Code Information
Lot # 18E031, exp 05/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated