Drug recall: 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation…
Class I FDA enforcement event 67092. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Baxter Healthcare Corp. started this drug recall on 21 Nov 2013. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class I. FDA event 67092 has 2 product records. The first FDA enforcement report date is 26 Mar 2014. The record gives the status Terminated, with the termination date 21 Sep 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Recalling firm
Baxter Healthcare Corp., Deerfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1162-2014 | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38. | 105,216 containers | Class I | Terminated | 26 Mar 2014 |
| D-1163-2014 | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation,… | 716,544 containers | Class I | Terminated | 26 Mar 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class I
- 18%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 83
Other events of the firm
Official channels
- FDA enforcement report D-1162-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 67092. https://recallregister.com/fda/i/67092/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
- What quantity of product is in FDA event 67092?
- The event has 2 product records. The first record gives this quantity:
105,216 containers
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 18% of the 370 drug events that started in 2013 are in Class I.