Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.

Recall Number: D-1513-2016

Firm: Sandoz Inc

Classification: Class II

Status: Terminated

Report Date: 20160928

Initiation Date: 20160824

Termination Date: 20170712

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.