Recalls / Class II
Class IID-1816-2015
Product
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose 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 #: P329821, Exp 08/31/2016
Why it was recalled
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Road #144, #250, N/A, Jayuya, Puerto Rico 00664-1503
Distribution
- Quantity
- 139,104 Bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-09-02
- FDA classified
- 2015-09-18
- Posted by FDA
- 2015-09-30
- Terminated
- 2016-09-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1816-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.