Drug product
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.
D-153-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 63548
- Status
- Completed
- Classification
- Class I
- Quantity
- 23,315 vials
- Official record key
drug-enforcement:D-153-2013
Official wording
Reason: Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Code information: Lot #: Z021650AA, Exp. 08/2013
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
particulates