American Regent Issues New Recall After Particulate Matter Found In Injectable Drug

<"">Caffeine and Sodium Benzoate Injection—USP, 250 mg/mL, 2 mL Single Dose Vial—has been recalled after particulate matter was found in this injectable drug, the U.S. Food and Drug Administration (FDA).

This recall was initiated at the user/consumer level and only involves Lot Number 0084; no other lots of Caffeine and Sodium Benzoate Injection, USP are subject to this voluntary recall. The recalled medication involves NDC Number 0517-2502-10 with an Expiration Date of February, 2012.

This recall was initiated because some of the vials of this lot may contain visible particulates. 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.

Intramuscular administration could also result in foreign body inflammation with local pain, swelling, and possible long-term granuloma formation.

Caffeine and Sodium Benzoate Injection has been used with supportive measures to treat respiratory depression linked to overdose of CNS depressant drugs—narcotic analgesics and alcohol, for example. Because of questionable benefit and transient action, most authorities believe caffeine and other analeptics should not be used in these conditions and recommend other supportive therapy.

This recalled medication was distributed to wholesalers and distributors nationwide. Hospitals, emergency rooms, clinics, and other healthcare facilities should not use the recalled American Regent Inc. Caffeine and Sodium Benzoate Injection for patient care and should immediately quarantine any product for return.

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 product should stop its use. American Regent will credit accounts for all returned product with this recalled lot number.

The American Regent Customer Service Department can be reached, toll-free, at 1.877.788.3232, Monday through Friday, from 8:30 a.m. to 7:00 p.m., Eastern Daylight Time (EDT). The American Regent Professional Services Department can be reached at 1.877.788.3232.

Adverse reactions should be reported to American Regent, Inc. via email at, by fax to 1.610.650.0170, or by telephone at 1.800.734.9236. Adverse reactions should also be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax: Online:; regular mail: use postage-paid, pre-addressed Form FDA 3500 available at: to be mailed to the address on the pre-addressed form; or by fax: 1-800-FDA-0178.

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