D-685-2013 Class II Terminated
FDA drug recall D-685-2013 was initiated by Fresenius Kabi USA, LLC on Jul 1, 2013 and is designated Class II. Reason for recall: Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials The recall status is terminated (terminated Oct 27, 2015). Affected quantity: 65110 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 17, 2013
- Initiation Date
- Jul 1, 2013
- Termination Date
- Oct 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65110 vials
Product Description
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
Reason for Recall
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Distribution Pattern
Nationwide & Puerto Rico
Code Information
a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-685-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026