Recalls / Class II
Class IID-685-2013
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
- Brand name
- Benztropine Mesylate
- Generic name
- Benztropine Mesylate
- Active ingredient
- Benztropine Mesylate
- Route
- Intramuscular, Intravenous
- NDC
- 63323-970
- FDA application
- ANDA090233
- Affected lot / code info
- a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
Why it was recalled
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 65110 vials
- Distribution pattern
- Nationwide & Puerto Rico
Timeline
- Recall initiated
- 2013-07-01
- FDA classified
- 2013-07-05
- Posted by FDA
- 2013-07-17
- Terminated
- 2015-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-685-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.