Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue...
FDA Recall #D-1087-2014 — Class II — November 6, 2013
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.
Recalling Firm
Actavis Elizabeth LLC — Elizabeth, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
13,608 bottles
Distribution
Nationwide
Code Information
lot 58468552 Exp. 05/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated