Drug product
Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02
D-685-2013
Product summary
- Event
- Event 65588
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65110 vials
- Official record key
drug-enforcement:D-685-2013
Official wording
Reason: Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Code information: a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
Distribution pattern: Nationwide & Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
particulate matter