Amerigen Pharmaceuticals Inc. recalls Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx
Recalled October 24, 2018 · FDA recall D-0249-2019 · Amerigen Pharmaceuticals
Hazard
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing. · FDA Class III
Units
5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
Sold at
Product was distributed U.S. nationwide.
Description
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Product
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.
Manufacturer(s)
Amerigen Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →