FDA recall D-1087-2014

Product

Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)

Reason for recall

Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-11-06

Report date

2014-03-05

Termination date

2014-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elizabeth, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1087-2014