Status
Terminated
Drug Enforcement D-685-2013
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Classification
Class II
Report Date
July 17, 2013
Termination Date
October 27, 2015
Product Information
- 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
- Product quantity
- 65110 vials
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide & Puerto Rico
Location & Firm
- Recalling firm
- Fresenius Kabi USA, LLC
- Address
-
3 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-685-2013
- Event ID
- 65588
- Recall initiation date
- July 1, 2013
- Center classification date
- July 5, 2013
- Code info
- a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
- More code info
- —