FDA recall D-0249-2019

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.

Reason for recall

Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.

Distribution

Product was distributed U.S. nationwide.

Key facts

Status

Terminated

Initiation date

2018-10-05

Report date

2018-10-24

Termination date

2019-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lyndhurst, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2019