CLASS II Drug recall · Reported 1 Apr 2015 · FDA Enforcement Report
9% Sodium Chloride Injection, USP in Viaflex recalled
Baxter Healthcare is recalling 9% Sodium Chloride 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-0425-2015
- FDA event ID
- 70770
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Sodium Chloride
- 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
- Foreign Material
- 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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
0.9% Sodium Chloride Injection, USP, 500 mL 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 0338-0049-03
Where it was distributed
Nationwide
Questions about this recall
Is 9% Sodium Chloride Injection, USP in Viaflex recalled?
Yes. Baxter Healthcare recalled 9% Sodium Chloride Injection, USP in Viaflex on 18 Mar 2015. The recall is Class II and its status is Terminated. Recall number D-0425-2015.
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 #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Baxter Healthcare
All 562| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
Other Sodium Chloride recalls
All 75| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride | Huons Co | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP 900 mg recalled by Fresenius Kabi USASodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP, 900 mg recalled by Fresenius Kabi USASodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP x60, Becton, Dickson recalledSodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP 9% (450 mg per (9 mg per mL) recalledSodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |