Status
Terminated
Drug Enforcement D-368-2014
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Classification
Class II
Report Date
December 25, 2013
Termination Date
June 10, 2015
Product Information
- Product description
- 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06.
- Product quantity
- 14,622 bags
- Reason for recall
- Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Baxter Healthcare Corp.
- Address
-
1 Baxter Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-368-2014
- Event ID
- 66820
- Recall initiation date
- November 12, 2013
- Center classification date
- December 17, 2013
- Code info
- Lot: P302646, Exp 5/31/15
- More code info
- —