Recalls / Class II
Class IID-1326-2015
Product
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, 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 #: C964601, Exp 4/30/2016
Why it was recalled
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
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
- 189,912 containers
- Distribution pattern
- TX and TN
Timeline
- Recall initiated
- 2015-07-02
- FDA classified
- 2015-08-12
- Posted by FDA
- 2015-08-19
- Terminated
- 2016-05-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1326-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.