Why it was recalled
Presence of Particulate Matter
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.
Lot numbers, UPCs & expiration codes
Lot # 7801050, Exp. Date. 05/2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1329-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 23, 2015
- FDA report date
- Aug 19, 2015
- Quantity
- 8,340 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional LLC
Original FDA data
Every field from FDA enforcement report D-1329-2015, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71079
- Address
- 4901 Hiawatha Dr
- Code information
- Lot # 7801050, Exp. Date. 05/2015
- Postal code
- 61103-1287
- Report date
- Aug 19, 2015
- Product type
- Drugs
- Recall number
- D-1329-2015
- Classification
- Class I
- Recalling firm
- Mylan Institutional LLC
- Product quantity
- 8,340 vials
- Termination date
- Jun 29, 2016
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 23, 2015
- Initial firm notification
- Press Release
- Center classification date
- Aug 13, 2015