American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials Due to Particulate Matter
Tue, 28 Dec 2010 14:57:00 -0600
American Regent is conducting a nationwide voluntary recall to the consumer and user level of ALL unexpired lots of the following products: Sodium Bicarbonate Injection, USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial NDC # 0517-0639-25 and Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL, Single Dose Vial NDC # 0517-1550-25 PLEASE NOTE: This recall, initiated on December 23, 2010 to the User or Consumer Level is for ALL unexpired lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials. See attached APPENDIX for ALL the lots subject to this voluntary recall. This voluntary recall was initiated because some vials of these lots contain particulates.
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U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
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