D-925-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 4, 2013
- Initiation Date
- August 1, 2013
- Termination Date
- February 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,185 vials
Product Description
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, Lincolnshire, IL 60069, NDC 14789-300-02
Reason for Recall
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Distribution Pattern
Nationwide
Code Information
a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14