CLASS I Drug recall · Reported 15 Jul 2015 · FDA Enforcement Report
Lactated Ringers Injection, USP Viafelx recalled by Baxter Healthcare
Baxter Healthcare is recalling Lactated Ringers Injection, USP Viafelx, distributed in Puerto Rico. The recall was initiated on 24 Mar 2015 and the FDA has classified it as Class I.
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-1211-2015
- FDA event ID
- 70926
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Lactated Ringers
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 24 Mar 2015
- FDA classified
- 6 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Mar 2015 | Recall initiated by company | |
| 6 Jul 2015 | Classified by FDA | +104 days |
| 15 Jul 2015 | Published in enforcement report | +9 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: Products recalled due to presence of particulate matter (metal)
Product as listed by the FDA
Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
Where it was distributed
US, Puerto Rico, and Bermuda
Questions about this recall
Is Lactated Ringers Injection, USP Viafelx recalled?
Yes. Baxter Healthcare recalled Lactated Ringers Injection, USP Viafelx on 24 Mar 2015. The recall is Class I and its status is Terminated. Recall number D-1211-2015.
Why was it recalled?
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Which lots are affected?
Lot #: C964619, C964056 and C964163, Exp 7/31/2016
Where was it sold?
US, Puerto Rico, and Bermuda
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
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|---|---|---|---|---|---|
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