1.9 Million Vials of Ephedrine Recalled

Allergy Laboratories is recalling 1.9 million vials of ephedrine sulfate injection, USP, 50 mg/mL.

What prompted the Class II recall? According to the US Food and Drug Administration’s Enforcement Report, the recall was launched after the agency’s inspection “raised concerns that product sterility was potentially impacted.”

Some were packaged as a 1 mL fill in a 2 mL vial (NDC 69053-008-01) and others as 25 x 2 mL vials (NDC 69053-008-02).

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The following lots are impacted:

• 102814, 102914, 103014, 103114, expiration October 2016;
• 110314, 110414, 110514, 110614, 110714, 111014, expiration November 2016;
• 121014, 121114, 121214, 121514, expiration December 2016;
• 011415, 011515, 011615, 012015, 012115, expiration January 2017;
• 021315, 021715, 021815, 021915, 022015, expiration February 2017;
• 030415, 030515, 030615, 031015, 031715, expiration March 2017;
• 042415, 042815, 042915, 043015, expiration April 2017;
• 050115, 050515, 052815, 052915, expiration May 2017;
• 060315, 060415, 061615, 061715, expiration June 2017.

The products were manufactured for Andersen Pharmaceuticals and distributed nationwide.

--Stephanie Vaccaro

Reference:

US Food and Drug Administration. FDA Enforcement Report – Week of September 14, 2016. www.fda.gov. Accessed September 14, 2016.