PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: August 19, 2015 Initiated: April 23, 2015 #D-1329-2015

Product Description

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.

Reason for Recall

Presence of Particulate Matter

Details

Recalling Firm
Mylan Institutional LLC
Units Affected
8,340 vials
Distribution
Nationwide
Location
Rockford, IL

Frequently Asked Questions

What product 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.. Recalled by Mylan Institutional LLC. Units affected: 8,340 vials.
Why was this product recalled?
Presence of Particulate Matter
Which agency issued this recall?
This recall was issued by the FDA Drug on August 19, 2015. Severity: Critical. Recall number: D-1329-2015.