FDA recall D-139-2013

Product

Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033

Reason for recall

Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-12-12

Report date

2013-02-06

Termination date

2014-01-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Piedras, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-139-2013