Fresenius Kabi recalls 4 lots of benztropine mesylate injection

July 3, 2013

Fresenius Kabi USA on June 30, 2013 issued a voluntary, user-level product recall of 4 lots of benztropine mesylate injection, USP, 2 mg/2 mL (1 mg/mL) in 2 mL single-dose vials, due to the possibility of glass particles in the vials.

Fresenius Kabi USA on June 30, 2013 issued a voluntary, user-level product recall of 4 lots of benztropine mesylate injection, USP, 2 mg/2 mL (1 mg/mL) in 2 mL single-dose vials, due to the possibility of glass particles in the vials. 

The specific lots recalled are lot 030712, expiration 03/2014; lot 071212, expiration 07/2014; lot 090512, expiration 09/2014; and lot 970102, expiration 11/2014.

The drug is used as an adjunct in the therapy of all forms of Parkinsonism. It is useful also in the control of extrapyramidal disorders due to neuroleptic drugs, except tardive dyskinesia.

To date, no adverse events, patient reactions, or customer complaints have been reported, and Fresenius Kabi has discontinued distribution of benztropine mesylate while it investigates the cause.

Customers who received the recalled vials are being notified and instructed to return any unused product to Fresenius Kabi USA. Any adverse reactions should be reported to the FDA’s MedWatch Adverse Event Reporting program

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