Benztropine Mesylate Injection Recall Issued Due to Particulate Matter

Two lots of an injection drug used to treat Parkinson’s disease have been recalled after vials were found to contain particulate matter, which could pose a health risk to users and an increased risk to those with mild to severe preexisting conditions.  

A Benztropine Mesylate Injection recall was announced by the FDA on August 1, after examination of the vials confirmed the presence of visible particulate matter. No injuries have been reported to government officials or the manufacturer.

Benztropine Mesylate injections, also sold under the brand name Cogentin, are commonly used to treat Parkinson’s disease and other forms of nerve disorders that cause loss of control or involuntary movement of muscles.

The recall includes single dose vials of Benztropine Mesylate Injection, USP 2 mg/2mL with lot numbers 030712 and 112911 and production code 1478930002 and also NDC number 1478-300-02.

The injection fluids were manufactured by Allergy Laboratories Inc., and distributed by and under the Nexus Pharmaceuticals name on 3/26/2012, 12/15/2011, 5/17/2012, and 3/26/2012 with expiration dates 3/2014 and 11/2013.

When particulate matter is present in injection fluids it may cause serious health hazards, such as thromboembolism, which typically results is blood clots but can be life threatening if not treated. Others injuries, such as mechanical blocks of capillaries or arterioles may occur. Users with pre-existing trauma conditions or other injuries that jeopardize blood supply are at an increased risk if particulate matter is injection into their blood stream.

Nexus Pharmaceuticals Inc. has begun contacting their distributors to arrange a return of all recalled lots of injection vials. Those with recalled injections lots should contact Nexus Pharmaceuticals Inc. at 888-806-4606 for further questions about the return policy.

The recall comes about a month after another Benzotropine Mesylate recall was announced by Fresenius Kabi. That recall came due to similar circumstances, with glass particles found in vials. No injuries were reported in connection to that recall.