FDA recall D-237-2013

Teva Pharmaceuticals USA, Inc. · Class II · drug

Product

CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96

Reason for recall

Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.

Distribution

Key facts

Status: Terminated
Initiation date: 2013-02-07
Report date: 2013-04-10
Termination date: 2014-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-237-2013