Allergy Laboratories, Inc. recalls Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01
Recalled September 14, 2016 · FDA recall D-1498-2016 · Allergy Laboratories
Hazard
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted. · FDA Class II
Units
1,928,075 vials
Sold at
Nationwide
Description
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
Manufacturer(s)
Allergy Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →