L-Cysteine Hydrochloride Injection recalled over sterility concerns

Recall date

November 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sandoz Inc recalls L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in…

Recall number

D-0140-2017

FDA classification

Class II

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide throughout the USA

Why it was recalled

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.