Amerigen Pharmaceuticals Inc. recalls Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx
Recalled January 2, 2019 · FDA recall D-0344-2019 · Amerigen Pharmaceuticals
Hazard
Failed Dissolution Specifications · FDA Class III
Units
3552 bottles
Sold at
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
Description
Failed Dissolution Specifications
Product
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
Manufacturer(s)
Amerigen Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →