Why it was recalled
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Product description
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.
Lot numbers, UPCs & expiration codes
lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
Where it was sold
Nationwide and Puerto Rico.
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-154-2013
- Classification
- Class I
- Status
- Completed
- Recall initiated
- Nov 8, 2012
- FDA report date
- Feb 13, 2013
- Quantity
- 31,326 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-154-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Completed
- Country
- United States
- Event ID
- 63548
- Address
- 275 N Field Dr
- Code information
- lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
- Postal code
- 60045-2579
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-154-2013
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 31,326 vials
- Termination date
- Mar 20, 2017
- Reason for recall
- Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Nov 8, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 6, 2013