Why it was recalled
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Product description
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
Lot numbers, UPCs & expiration codes
Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
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-068-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 8, 2012
- FDA report date
- Dec 5, 2012
- Quantity
- 1,319 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline, LLC.
Original FDA data
Every field from FDA enforcement report D-068-2013, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 63691
- Address
- 1011 North Arendell Ave
- Code information
- Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
- Postal code
- 27597-1217
- Report date
- Dec 5, 2012
- Product type
- Drugs
- Recall number
- D-068-2013
- Classification
- Class II
- Recalling firm
- GlaxoSmithKline, LLC.
- Product quantity
- 1,319 vials
- Termination date
- Sep 11, 2014
- Reason for recall
- Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 8, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 27, 2012