FDA-Drug2016-11-23Class II
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), 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 the product sterility may be compromised.
Sold states
Nationwide throughout the USA
Affected count
18,751 vials
Manufactured in
100 College Rd W, N/A, Princeton, NJ, United States
Products
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0140-2017Don't want to check this manually?
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