American Regent recalls Dexamethasone Sodium Phosphate Injection

American Regent just initiated a voluntary recall of <"">Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose Vial NDC # 0517-4930-25, the <"">U.S. Food and Drug Administration (FDA) just announced.

Following are the lot numbers and expiration dates involved:

• Lot 8811; expiration date 12/2010
• Lot 9093; expiration date 02/2011
• Lot 9195; expiration date 03/2011
• Lot 9296; expiration date 04/2011
• Lot 9419; expiration date 06/2011
• Lot 9505; expiration date 07/2011
• Lot 9649; expiration date 09/2011

The FDA notes that, this recall, initiated on December 20, 2010 to the User Level, is for these lots only. No other lots of the 30 mL MDV or other sizes of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, are subject to this recall.

This voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. American Regent is undertaking this recall in consideration of the potential for safety issues if these lots of product are administered to patients.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 30 mL Multiple Dose Vials with the lot numbers indicated here for patient care and should immediately quarantine any product for return.

“Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks,” said Mary Jane Helenek, President and CEO of American Regent.

As is standard practice, and as stated in the Dexamethasone Sodium Phosphate Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

American Regent will credit accounts for all returned product with the involved lot numbers. Those with questions about the return process should call American Regent Customer Service at 1-800-645-1706, Monday thru Friday, from 8:30 a.m. to 7:00 p.m., Eastern Time.

Hospitals, infusion centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 800-645-1706.

Dexamethasone Sodium Phosphate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc., Shirley, New York.

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