FDA recall D-1498-2016

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.

Reason for recall

Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-08-10

Report date

2016-09-14

Termination date

2017-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oklahoma City, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1498-2016