FDAFDA · Food and drugs·Recall number D-685-2013
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
Published July 17, 2013 · Recall initiated: July 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BENZTROPINE MESYLATE
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide & Puerto Rico
- Lot
- a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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