Baxter Receives FDA OK for Spanish Mfg Site for NaCl IV Product

Baxter International Inc. reports that the US Food and Drug Administration (FDA) has approved the company’s supplemental drug application to establish its Sabinanigo, Spain, facility as an approved manufacturing site for 0.9% sodium chloride injection, USP, for the US market.

The approval includes product presentations in 250 mL, 500 mL and 1000 mL, which Baxter has been distributing in the US to alleviate a drug shortage with the knowledge of the FDA. All three of these product presentations of 0.9% sodium chloride injection, USP, more commonly known as saline, have been listed in drug shortage databases maintained by FDA and the American Society of Health-System Pharmacists over the past two years.

In April 2015, Baxter voluntarily recalled eight lots of sodium chloride injection (USP), four lots of dextrose injection (USP), and three lots of lactated ringer’s injection to the hospital/user level due to the potential presence of particulate matter. The problem was discovered by Baxter manufacturing personnel while performing routine maintenance under which particulate matter was detected and identified as material from a solution transmission system pump. There have been no adverse events or product complaints associated with this issue reported to Baxter.

Sodium chloride injection, USP is indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. Dextrose injection, USP is indicated as a source of water and calories. Lactated ringer's injection, USP is indicated as a source of water and electrolytes, or as an alkalinizing agent. The lots recalled were distributed to customers and distributors in the United States and Bermuda between January 14, 2015 and March 5, 2015.

In December 2014, Baxter s voluntarily initiated a recall in the United States of two lots of 0.9% sodium chloride injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall was initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter. The issue was identified upon standard visual inspection prior to patient administration.

Source: Baxter International

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