Baxter International ($BAX) had to recall two lots of saline solution earlier this month after customers discovered insects in some containers. Now the drugmaker is recalling more saline, as well as another replenishment product and an antibiotic, after customers complained of particulate matter that turned out to be cardboard, cloth and dried skin.
On Tuesday, the Deerfield, IL, company voluntarily recalled two lots of its 100mL in Mini-Bag Plus Container saline, one because of the cardboard and one because 11 bags were discovered to be leaking. The company said that the leaking bags were tracked back to a problem with a machine that occurred on a single shift and that the problem has been fixed.
The cloth was found in a container of metronidazole injection, an antibiotic used against serious infections, while the skin was found in a container of the replenishment product, Clinimix E 5/15, a mix of 5% amino acid with electrolytes in 15% dextrose with calcium.
Baxter, along with other manufacturers, upped its saline production at the request of the FDA two years ago as a shortage materialized. But constant recalls have hampered efforts to get the U.S. saline supply stocked to the point of resolving the shortage. Last fall, Baxter had to recall nearly 140,000 bags of sodium chloride due to the possibility that some of the saline solution bags contained mold. Hospira has also had to recall some of its saline supplies.
In the midst of this, some senators have raised questions about why it has taken so long to resolve the shortage, asking the FTC to investigate whether there has been collusion among producers. They directed the agency to also probe whether the three key saline producers--Baxter, Hospira and Braun--are using the situation to sell other equipment by tying saline sales to things like "pumps, tubing, and catheters." The companies have denied colluding, pointing to their efforts to help the FDA and the industry resolve the shortage.
- here's the announcement