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12-28-2010, 05:10 PM #1
American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection
American Regent is conducting a nationwide voluntary recall tothe 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 VialNDC # 0517-0639-25andSodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL, Single Dose VialNDC # 0517-1550-25PLEASE NOTE: This recall, initiated on December 23, 2010 to the User or ConsumerLevel is for ALL unexpired lots of Sodium Bicarbonate Injection, USP, 7.5% and8.4%, 50 mL Single Dose Vials. See attached APPENDIX for ALL the lots subject tothis voluntary recall.This voluntary recall was initiated because some vials of these lots contain particulates.