FDAClass IAugust 19, 2015

Cytarabine Injection 100 mg/5 mL recall: Particulate Matter

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.

Why was Cytarabine Injection 100 mg/5 mL recalled?

Presence of Particulate Matter

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 7801050, Exp. Date. 05/2015

Product
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.
Recalling firm
Mylan Institutional LLC
Quantity
8,340 vials
Distribution
Nationwide
Recall date
August 19, 2015
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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