Amerigen Pharmaceuticals Inc. recalls Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx
Recalled February 27, 2019 · FDA recall D-0516-2019 · Amerigen Pharmaceuticals
Hazard
Failed dissolution specifications · FDA Class III
Units
a) 2,413 bottles b) 3,355 bottles
Sold at
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
Description
Failed dissolution specifications
Product
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Manufacturer(s)
Amerigen Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →