Why it was recalled
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Product description
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Lot numbers, UPCs & expiration codes
Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14
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-928-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 13, 2013
- FDA report date
- Sep 11, 2013
- Quantity
- 780 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-928-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 65959
- Address
- 650 Cathill Rd
- Code information
- Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14
- Postal code
- 18960-1512
- Report date
- Sep 11, 2013
- Product type
- Drugs
- Recall number
- D-928-2013
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 780 vials
- Termination date
- Aug 27, 2014
- Reason for recall
- Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Sep 3, 2013