Recalls / Class II
Class IID-1514-2019
Product
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, 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
- Lot #s: P389684; P389742, Exp. 8/31/2020
Why it was recalled
Lack of Assurance of Sterility: Bags have potential to leak.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 139,680 Containers
- Distribution pattern
- Nationwide in the United States and Puerto Rico.
Timeline
- Recall initiated
- 2019-07-18
- FDA classified
- 2019-07-23
- Posted by FDA
- 2019-07-31
- Terminated
- 2021-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1514-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.