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Recall Observatory FDA recall evidence

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

July 01, 2013

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
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

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter