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9 May 2011

American Regent Recalls Caffeine & Sodium Benzoate Injection

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

American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product: Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial, NDC # 0517-2502-10, Lot #0084, Exp Date  February, 2012.

 

This recall, initiated on May 5, 2011 to the User or Consumer Level, is for Lot # 0084 Only.  No other lots of Caffeine & Sodium Benzoate Injection, USP are subject to this voluntary recall.

 

This voluntary 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 a

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