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…

Recall date

February 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0516-2019

FDA classification

Class III

Brand / firm

Amerigen Pharmaceuticals Inc.

Sold / distributed

Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.

Why it was recalled

Failed dissolution specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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