Status
Terminated
Drug Enforcement D-928-2013
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Classification
Class II
Report Date
September 11, 2013
Termination Date
August 27, 2014
Product Information
- Product description
- CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
- Product quantity
- 780 vials
- Reason for recall
- Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Address
-
650 Cathill Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-928-2013
- Event ID
- 65959
- Recall initiation date
- August 13, 2013
- Center classification date
- September 3, 2013
- Code info
- Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14
- More code info
- —