Recalls / Class II
Class IID-623-2013
Product
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
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDC
- 0338-0553
- FDA application
- NDA020178
- Affected lot / code info
- Lot: P293118; Exp Date: 10/13
Why it was recalled
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.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 317,280 bags
- Distribution pattern
- Nationwide and Singapore
Timeline
- Recall initiated
- 2013-02-27
- FDA classified
- 2013-06-27
- Posted by FDA
- 2013-07-03
- Terminated
- 2015-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-623-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.