Drug 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.
D-1329-2015
Product summary
- Event
- Event 71079
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8,340 vials
- Official record key
drug-enforcement:D-1329-2015
Official wording
Reason: Presence of Particulate Matter
Code information: Lot # 7801050, Exp. Date. 05/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter