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| 5% Dextrose and 0.45% Sodium Chloride Injection, USP; the 1000 mL container was one of the products Hospira recalled--Courtesy of Hospira |
In its most recent recall notice Hospira ($HSP) says simply that it is recalling "certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage." But the description does not get to the depth and breadth of the recall, which is for 54 lots of nearly a dozen products. That includes two dozen lots of saline solution in the 1000-mL size, an essential hospital product that has been in short supply for months.
The 11 products being recalled are from Hospira's LifeCare flexible intravenous solutions line. The Lake Forest, IL-based drugmaker said there is a chance they have a single puncture mark that goes through the overwrap and primary container. While it said he has received no reports of adverse reactions, the puncture can cause leakage that is "difficult to detect" and poses the risk for contamination. The lots, some of which were shipped as recently as this month, date back to September of last year.
Hospira said it found the problem after reinspection of a manufactured lot and tracked the manufacturing issue back to a "conveyance system." The company said it has fixed the problem so it won't recur.
Hospira said in an emailed comment that the recall will have no affect on its production capabilities and that it believes most of the recalled products "have already been used in accordance with the information we provided customers in February." It said customers can call for replacement products.
The company said it has been maximizing its saline production to help deal with the shortage and is "producing product at full capacity."
A shortage of saline materialized last year after some product recalls by several companies and then a big uptake in use during the last flu season. Saline is a product that the U.S. healthcare system uses millions of times a week, but the shortage has made hospitals rethink their usage so they don't run out.
The FDA has been scrambling to help hospitals maintain supplies. It has been working with Hospira, Baxter International ($BAX) and B. Braun Medical, to boost their U.S. production and has also allowed products to be imported from two European plants that were not approved to ship saline to the U.S., a Fresenius Kabi plant in Norway and a Baxter plant in Spain. Even with those added supplies, the shortage has persisted.
- here's the announcement