Recalls / Class II
Class IID-0973-2017
Product
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0338-0043, 0338-0049
- FDA application
- NDA018016
- Affected lot / code info
- Lots: P361501, P361667, and P361790, Exp 09/30/18
Why it was recalled
Lack of Assurance of Sterility: Bags have the potential to leak.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 295,200 bags
- Distribution pattern
- Nationwide, Puerto Rico and Saudi Arabia
Timeline
- Recall initiated
- 2017-07-06
- FDA classified
- 2017-07-11
- Posted by FDA
- 2017-07-19
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0973-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.