Drug product
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
D-928-2013
Product summary
- Event
- Event 65959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 780 vials
- Official record key
drug-enforcement:D-928-2013
Official wording
Reason: Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Code information: Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility