Product: 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.
Reason for recall: Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Recall initiated: 20161109
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated