Recalls / Class II
Class IID-1583-2014
Product
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
- 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
- Lot #C926642, Product Code: 2B1323N
Why it was recalled
Lack of Assurance of Sterility; complaints of mold in the overpouch
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
- 157,080 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-30
- FDA classified
- 2014-09-05
- Posted by FDA
- 2014-09-17
- Terminated
- 2016-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1583-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.