Mylan Institutional LLC recalls Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per…

Recall date

April 23, 2015

Source

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

Recall number

D-1329-2015

FDA classification

Class I

Brand / firm

Mylan Institutional LLC

Sold / distributed

Nationwide

Why it was recalled

Presence of Particulate Matter

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.