Drug 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, Lincolnshire, IL 60069, NDC 14789-300-02
D-925-2013
Product summary
- Event
- Event 65853
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46,185 vials
- Official record key
drug-enforcement:D-925-2013
Official wording
Reason: Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Code information: a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter