Baxter Recalls Over 139k Bags of Sodium Chloride Injection

Baxter Healthcare is recalling 139,104 bags of 0.9 percent sodium chloride injection produced at the company’s maligned Jayuya, Puerto Rico, facility following complaints of mold on the interior surface of the overpouch — the firm’s ninth recall since December 2013.

Baxter initiated the nationwide recall of one lot of product on Sept. 2. The FDA has designated it Class II.

The Jayuya facility received a six-observation FDA Form 483 in late May for lapses in sterile process controls and failure to review batch discrepancies. Among other issues, the form notes that on four occasions between September and October 2014, the quality control laboratory reported out-of-limit or out-of-specification results for 0.9 percent sodium chloride injection.

The form also notes that between January and March of this year, Baxter received complaints about missing or loose blue tip port protectors for IV solution products — the source of three of the company’s recalls this year.

The recalls come during a continued shortage of sodium chloride injection. Baxter did not return a request for comment by press time. — Kellen Owings