More woes for the U.S. supply of saline solution as Baxter International ($BAX) announced another voluntary recall of its products. This time, two lots of intravenous solutions have been recalled due to the presence of particulate matter after a customer complained of an insect found in the product, the FDA said.
The lots being recalled are for 0.9% sodium chloride injection, USP, 250-milliliter Viaflex plastic container used for IVs and 70% dextrose injection (2,000 milliliter) USP. Both products are typically used for caloric intake and hydration of patients. The lots were distributed in the U.S. between June 6 and Dec. 16 last year.
Using the product could result in blood vessel blockage, which can cause a stroke, heart attack or damage to other major organs as well as possible allergic reactions.
The recall isn't expected to affect current supply and product remains available for current customers, the agency said.
In October, the Deerfield, IL, company recalled nearly 140,000 bags of sodium chloride due to the possibility some of the saline solution bags contained mold. That voluntary recall was initiated after Baxter received a complaint of mold on the interior surface of an overpouch, which was made at its plant in Jayuya, Puerto Rico. That facility got an FDA warning letter two years ago for a number of problems, including 20 nonconformance reports on liquid products containing everything from skin to human hair to rayon.
For about three years now, the U.S. has been battling shortages of saline, one of the most frequently used products in hospitals. To help replenish the nation's supply chain, it has allowed the import of product from some plants in Europe that were not previously approved for U.S. distribution. A Baxter plant in Spain was approved last year, and the agency has also granted temporary permission to a Fresenius Kabi plant in Norway and a B. Braun plant in Germany.
However, repeated recalls by Baxter and Hospira have kept the U.S. supply chain from getting fully replenished. Baxter has had a number of recalls of saline this year amounting to hundreds of thousands of bags. One recall of three lots in April last year alone accounted for 600,000 bags of product. It recalled two lots in July because of particulate that turned out to be insects.
- see the FDA posting