FDA-Drug2016-09-28Class II
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.
Sandoz Inc
Hazard
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Sold states
Nationwide and Puerto Rico
Affected count
32,099 cartons
Manufactured in
100 College Rd W, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1513-2016Don't want to check this manually?
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