CLASS II Drug recall · Reported 1 Apr 2015 · FDA Enforcement Report
5% Dextrose Injection, USP in Viaflex recalled by Baxter Healthcare
Baxter Healthcare is recalling 5% Dextrose Injection, USP in Viaflex, distributed nationwide in the US. The recall was initiated on 18 Mar 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0426-2015
- FDA event ID
- 70770
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Dextrose
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2015
- FDA classified
- 25 Mar 2015
- Reported
- 1 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Mar 2015 | Recall initiated by company | |
| 25 Mar 2015 | Classified by FDA | +7 days |
| 1 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Which lots are affected?
Lot #: C926899, Exp 7/31/2015
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 70770| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 0.9% Sodium Chloride Injection, USP in Viaflex recalledSodium Chloride | Baxter Healthcare | Sterility | Nationwide |
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
Other Dextrose recalls
All 44| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Dextrose Injection recalled by B Braun MedicalDextrose | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |