Posted from: Tuesday, July 16, 2013 - 03:47 PM - Present

DRUG RECALL - Benztropine Mesylate Used for Treatment of Tremors

June 30, 2013, Fresenius Kabi USA issued a voluntary recall of Benztropine Mesylate Injection, USP, 2 mg/2 mL in 2 mL single dose vials. The recall has been issued due to glass particles found in vials. If the particles go unnoticed and are injected there is a potential for severe injury.

Benztropine Mesylate is used to treat symptoms of Parkinson’s disease and tremors caused by other drugs or diseases. 

The affected lots include the following: 

Product Name/ Strength/Size

NDC Number

Lot Number

Expiration Date

Benztropine Mesylate Injection, USP 2 mg/2 mL (1 mg/mL), 2 mL Single Dose Vial

14789-300-02

030712

03/2014

071212

07/2014

63323-970-02

090512

09/2014

111412

11/2014

If you have this product, it is suggested that you cease its use and return any remaining medication to your pharmacy.  If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.

Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

Online: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.  Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

Last Updated Monday, May 29, 2017 - 07:37 AM.