FDA recall D-0344-2019

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

Reason for recall

Failed Dissolution Specifications

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-12-20

Report date

2019-01-02

Termination date

2019-12-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lyndhurst, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0344-2019