BETHESDA, MD 24 Feb 2015—
Sagent Pharmaceuticals Inc.
on Monday announced it was recalling six lots of atracurium besylate 10-mg/mL injection vials because an FDA inspection of the contract manufacturer's site revealed practices that could affect product sterility.
The six lots are VATA012 and VATA015, which are 5-mL single-dose vials, and VATB012, VATB013, VATB014, and VATB017, which are 10-mL multidose vials.
Distribution of the vials in these lots to hospitals, wholesalers, and distributors occurred from February 2014 through February 2015, Sagent said.
The company said customers are being told to examine their inventory immediately, quarantine all vials from the six lots, and notify all downstream distributers about the recall. The direct notification to customers, the company said, includes instructions on returning the recalled vials.
Questions about the recall should be directed to Sagent's customer call center at 866-625-1618, Monday–Friday 8 a.m. to 7 p.m. CST.
Sagent said its atracurium vials are now manufactured at the company's own facility.
The company identified Emcure Pharmaceuticals Limited as the contract manufacturer of the atracurium vials being recalled.