Baxter International ($BAX), which has faced FDA criticism for operations at some of its plants, is recalling 5 lots of products after particulate was found in two different solutions. While the FDA was the agency to issue a MedWatch alert, the recall goes well beyond the U.S.
The drugmaker said it is voluntarily recalling at the hospital and user level a single lot of 5% dextrose injection, USP and four lots of 0.9% sodium chloride injection. The recall is for products shipped to Singapore, Saudi Arabia and the United Arab Emirates as well as the U.S. and Puerto Rico.
Dextrose is injected into patients as a source of water and calories, while sodium chloride is injected as a source of water and electrolytes and used as a priming solution in hemodialysis. The company said there have been no reports of problems but warned that an injection of particles can cause allergic reactions or even blockages that could lead to a stroke or heart attack.
The FDA last year issued a warning letter to Baxter for its plant in Jayuya, Puerto Rico, along with a plant in Marion, NC, where inspectors noted mold in the filling area. The FDA said in the May 2013 warning letter that both facilities had not gotten on top of problems observed in earlier visits. Among other problems at the Marion plant, the FDA criticized Baxter for not getting to the root of mold problems that led it to stop production on its large-volume parenteral line.
The FDA said at the Puerto Rico facility, which had been cited previously, Baxter reported 20 nonconformance reports on liquid products containing everything from skin to human hair to rayon and that there was no indication that its processes were sound enough to prevent the problem on an ongoing basis. It also was was criticized for how it handled problems with leaky solution bags.
- here's the recall announcement
- here's the FDA MedWatch safety alert