Sandoz Inc recalls L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x
Recalled November 23, 2016 · FDA recall D-0141-2017 · Sandoz
Hazard
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised. · FDA Class II
Units
33,624 vials
Sold at
Nationwide throughout the USA
Description
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Product
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
Manufacturer(s)
Sandoz Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →