FDA recall D-925-2013

Product

Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, 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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-08-01

Report date

2013-09-04

Termination date

2016-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-925-2013