CLASS II Drug recall · Reported 19 Aug 2015 · FDA Enforcement Report
9% Sodium Chloride Injection USP in Viaflex recalled
Baxter Healthcare is recalling 9% Sodium Chloride Injection USP in Viaflex, Baxter Healthcare Corporation Deerfield, IL, distributed in Tennessee, Texas. The recall was initiated on 2 Jul 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-1326-2015
- FDA event ID
- 71627
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Sodium Chloride
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jul 2015
- FDA classified
- 12 Aug 2015
- Reported
- 19 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jul 2015 | Recall initiated by company | |
| 12 Aug 2015 | Classified by FDA | +41 days |
| 19 Aug 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
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Product as listed by the FDA
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Where it was distributed
TX and TN
Questions about this recall
Is 9% Sodium Chloride Injection USP in Viaflex, Baxter Healthcare Corporation Deerfield, IL recalled?
Yes. Baxter Healthcare recalled 9% Sodium Chloride Injection USP in Viaflex, Baxter Healthcare Corporation Deerfield, IL on 2 Jul 2015. The recall is Class II and its status is Terminated. Recall number D-1326-2015.
Why was it recalled?
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Which lots are affected?
Lot #: C964601, Exp 4/30/2016
Where was it sold?
TX and TN
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
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|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 9% Sodium Chloride Injection USP, Viaflex recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
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Other Sodium Chloride recalls
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 9% Sodium Chloride Injection USP, Viaflex recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| 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 |