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, R…

Recall date

December 20, 2018

Source

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

Recall number

D-0344-2019

FDA classification

Class III

Brand / firm

Amerigen Pharmaceuticals Inc.

Sold / distributed

Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.

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, 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