FDAClass IISeptember 4, 2013

Benztropine Mesylate Injection recall: Particulate Matter

Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc…

Why was Benztropine Mesylate Injection recalled?

Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14

Product
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc…
Recalling firm
Nexus Pharmaceuticals Inc
Quantity
46,185 vials
Distribution
Nationwide
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls