Sandoz Inc recalls 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
Recalled September 28, 2016 · FDA recall D-1513-2016 · Sandoz
Hazard
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. · FDA Class II
Units
32,099 cartons
Sold at
Nationwide and Puerto Rico
Description
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Product
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.
Manufacturer(s)
Sandoz Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →