American Regent recalls dexamethasone sodium phosphate, sodium bicarbonate injections

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Dec 30, 2010
By dvm360.com staff
National Report -- Numerous lots of dexamethasone sodium phosphate and sodium bicarbonate injections have been recalled due to the presence of particulates, according to the U.S. Food and Drug Administration.

In a series of three alerts Dec. 20 and 23, FDA says American Regent initiated the recalls which affect the following products:

• Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 30 mL Multiple Dose Vial NDC #0517-4930-25, lot numbers 8811, 9093, 9195, 9296, 9419, 9505, and 9649;
• Sodium Bicarbonate Injection, USP, 7.5 percent, 44.6/50 mL Single Dose Vial NDC #0517-0639-25, lot numbers 8833, 9130, 9342, 9543, 9702, 0068, 0276, 0581, 0745; and
• Sodium Bicarbonate Injection, USP, 8.4 percent, 50 mEq/50 mL Single Dose Vial NDC #0517-1550-25, lot numbers 8845, 9062, 9058, 9111, 9128, 9158, 9180, 9212, 9262, 9271, 9292, 9346, 9346A, 9360, 9374, 9396, 9412, 9438, 9720, 9801, 9821, 0054, 0115, 0162, 0172, 0237, 0427, 0528, 0597, 0649.

“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,” reports FDA.

The affected products were sent to distributors and wholesalers nationwide. American Regent will credit all accounts for returned products with the affected lot numbers, according to FDA. Questions can be directed to the company at 1-800-645-1706, and adverse reactions should be reported to 1-800-734-9236.

No reactions have been reported so far, and American Regent says the recall is a voluntary, precautionary measure.