D-1087-2014 Class II Terminated

Recalled by Actavis Elizabeth LLC — Elizabeth, NJ

FDA drug recall D-1087-2014 was initiated by Actavis Elizabeth LLC on November 6, 2013 and is designated Class II. Reason for recall: Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification. The recall status is terminated (terminated June 2, 2014). Affected quantity: 13,608 bottles.

Recall Details

Product Type
Drugs
Report Date
March 5, 2014
Initiation Date
November 6, 2013
Termination Date
June 2, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,608 bottles

Product Description

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 Pattern

Nationwide

Code Information

lot 58468552 Exp. 05/15