Recalls / Class II
Class IID-928-2013
Product
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
- Affected lot / code info
- Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 780 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-13
- FDA classified
- 2013-09-03
- Posted by FDA
- 2013-09-11
- Terminated
- 2014-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-928-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.