Baxter International ($BAX) issued a four-country recall two weeks ago of some of its injected products because particulate had been found in some of it. Now, in the U.S., it is recalling three lots of its Clinimix line of parenteral nutrition products for the same reason.
The company said on Friday it was voluntarily recalling two lots of Clinimix and one lot of Clinimix E injections to the user level due to complaints of particulate matter found in the products. The premixed sterile intravenous parenteral nutrition products come in multichambered containers and were shipped only in the U.S. It said there had been no adverse reaction reports but warned that injected particulate could cause health problems, including strokes or heart attacks.
That was the same warning the company gave on Dec. 23 when it voluntarily recalled at the hospital and user level a single lot of 5% dextrose injection, USP and four lots of 0.9% sodium chloride injection. That recall is for products shipped to Singapore, Saudi Arabia and the United Arab Emirates as well as the U.S. and Puerto Rico.
The company has had issues with its parenteral manufacturing. Last year, the FDA 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.