Persistent Particulate Issues Cause Another Baxter Recall

Baxter International issued its sixth recall of intravenous solutions since December 2013, recalling 15 lots — about 237,000 units — because of the potential presence of particulate matter.

The sodium chloride recall comes in the midst of an ongoing saline shortage. Last April, Baxter agreed to temporarily distribute saline in the U.S. from its Sabinanigo, Spain, manufacturing facility to help boost industry supplies. The company has not recalled any of those imported saline products, spokesman John O’Malley said.

Sodium chloride injections have been involved in five of Baxter’s six previous particulate-induced recalls, albeit in varying sizes.

The company’s last three such recalls in December, August and July all featured the injections, and its December 2013 recall included it as well as a 5 percent dextrose injection.

Baxter says the particulate matter was discovered during routine maintenance and identified as material from a solution transmission system pump. The firm says it has not received any adverse event reports or product complaints related to the issue.

Eight lots of 0.9 percent sodium chloride injection, USP 250 ml, two lots each of 5 percent and 10 percent dextrose injection, USP 250 ml, and three lots of Lactated Ringer’s injection, USP 250 ml, are affected.

The affected lots were distributed to customers and distributors in the U.S. and Bermuda between Jan. 14 and March 5.

To read the recall notice and see the full list of affected lots, go to www.fdanews.com/04-13-15-BaxterRecall.pdf. — Kellen Owings