Status
Terminated
Drug Enforcement D-623-2013
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Classification
Class II
Report Date
July 3, 2013
Termination Date
May 11, 2015
Product Information
- Product description
- 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
- Product quantity
- 317,280 bags
- Reason for recall
- Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Singapore
Location & Firm
- Recalling firm
- Baxter Healthcare Corp.
- Address
-
1 Baxter Pkwy
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-623-2013
- Event ID
- 65061
- Recall initiation date
- February 27, 2013
- Center classification date
- June 27, 2013
- Code info
- Lot: P293118; Exp Date: 10/13
- More code info
- —