Recalls / Class II
Class IID-0429-2015
Product
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
- 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
- Product code: 2B1308; Lot#: P316497, exp date: 10/2015
Why it was recalled
Lack of Assurance of Sterility; increased complaints received for leaks
Recalling firm
- Firm
- Baxter Healthcare Corp
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 196,128 containers
- Distribution pattern
- Nationwide and Singapore
Timeline
- Recall initiated
- 2015-03-23
- FDA classified
- 2015-03-31
- Posted by FDA
- 2015-04-08
- Terminated
- 2016-10-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0429-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.