Recalls / Class II
Class IID-0972-2017
Product
5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38
- Brand name
- Dextrose
- Generic name
- Dextrose Monohydrate
- Active ingredient
- Dextrose Monohydrate
- Route
- Intravenous
- NDCs
- 0338-0017, 0338-0023
- FDA application
- NDA016673
- Affected lot / code info
- Lot: P361618, Exp 09/30/18;
Why it was recalled
Lack of Assurance of Sterility: Bags have the potential to leak.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 54,528 bags
- Distribution pattern
- Nationwide, Puerto Rico and Saudi Arabia
Timeline
- Recall initiated
- 2017-07-06
- FDA classified
- 2017-07-11
- Posted by FDA
- 2017-07-19
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0972-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.