Glass Particles Prompt Recall for American Regent Methyldopate HCL Injection

The U.S Food and Drug Administration (FDA) just announced a recall of defective <"">Methyldopate HCL Injection. This recall was initiated because some vials of this lot contained translucent visible particles consistent with glass delamination. The glass particles (flakes) ranged in size from <50 microns to 200 microns.

Methyldopate HCL Injection, USP is used to treat hypertension when parenteral medication is indicated.

The defective Methyldopate HCL Injection involved is USP, 250 mg/5 mL (50mg/mL), 5 mL Single Dose Vial
NDC # 0517-8905-10, Lot # 0152, Exp Date March, 2012. The recall was initiated at the User or Consumer Level and is for Lot # 0152 only. No other lots of Methyldopate HCL Injection, USP are subject to this voluntary recall.

Some of the potential adverse events after intravenous administration of solutions containing particulates may include: Disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation. To date, American Regent has not received any reports of adverse events related to this recall.

The product was distributed to wholesalers and distributors nationwide. Hospitals, emergency rooms, clinics, and other healthcare facilities and providers should not use American Regent Inc., Methyldopate HCL Injection, USP, 250mg/5mL, Single Dose Vials, with Lot # 0152, for patient care and should immediately quarantine any product for return. Meanwhile, American Regent is notifying its distributors and consumers by email, facsimile, and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers in possession of the recalled injection should stop its use. Also, hospitals, emergency rooms, clinics, and other healthcare facilities and providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the firm’s Professional Services Department at 1.877.788.3232.

American Regent will credit accounts for all returned Methyldopate HCL Injection, USP, 250mg/5mL, Single Dose Vials, with Lot # 0152. Those with questions about the return or recall process should call the firm’s Customer Service Department, toll-free, at 1.877.788.3232, Monday through Friday from 8:30 a.m. to 7:00 p.m., Eastern Daylight Time (EDT).

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via e-mail at, by fax to (610) 650-0170, or by phone at 1-800-734-9236. Adverse reactions or quality problems experienced with the use of this product/lot should also be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax: Online at; by regular mail, use postage-paid, pre-addressed Form FDA 3500 available at: Mail to address on the pre-addressed form; or by fax at 1-800-FDA-0178.

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