FDA-Drug2016-09-14Class II
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.
Allergy Laboratories, Inc.
Hazard
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Sold states
Nationwide
Affected count
1,928,075 vials
Manufactured in
1005 SW 2nd St, Oklahoma City, OK, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1498-2016Don't want to check this manually?
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