January 08, 2021
Sterility concerns have prompted Merck Sharp & Dohme to issue a voluntary recall of all unexpired lots of Zerbaxa (ceftolozane and tazobactam) 1.5 g/vial for injection. According to the January 6, 2021, US Food and Drug Administration (FDA) Enforcement Report, seven batches of Zerbaxa failed to meet sterility specifications.
“Five of these batches tested positive for Ralstonia pickettii, and two batches produced turbid results that could not be further identified,” the report stated. “While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.”
The recall affects Zerbaxa (ceftolozane and tazobactam) 1.5 g/vial for injection (NDC 67919-030-01) from lots SP1488 (Exp. 6/8/21), SP1490 (Exp. 6/11/21), SP1492 (Exp. 6/13/21), SP1493 (Exp. 6/15/21), SP1494 (Exp. 6/21/21), SP1495 (Exp. 6/23/21), SP1496 (Exp. 6/25/21), SP1497 (Exp. 6/27/21), SP1498 (Exp. 6/29/21), SP1509 (Exp. 9/20/21), SP1510 (Exp. 9/26/21), SP1515 (Exp. 10/16/21), SP1517 (Exp. 10/23/21), SP1518 (Exp. 10/25/21), SP1519 (Exp. 10/30/21), SP1520 (Exp. 11/1/21), SP1521 (Exp. 11/6/21), SP1522 (Exp. 11/8/21), SP1523 (Exp. 11/13/21), SP1524 (Exp. 11/15/21), SP1525 (Exp. 11/20/21), SP1526 (Exp. 11/27/21), SP1537 (Exp. 1/11/22), SP1564 (Exp. 10/17/22), SP1567 (Exp. 10/16/22), SP1572 (Exp. 10/24/22), SP1573 (Exp. 10/28/22), SP1574 (Exp. 10/29/22), SP1584 (Exp. 11/14/22), SP1586 (Exp. 11/15/22), SP1588 (Exp. 11/19/22), SP1593 (Exp. 12/3/22), SP1602 (Exp. 12/18/22), SP1603 (Exp. 12/19/22), SP1606 (Exp. 1/8/23), SP1609 (Exp. 1/15/23), SP1610 (Exp. 1/20/23), SP1611 (Exp. 1/22/23), SP1626 (Exp. 4/13/23), SP1629 (Exp. 4/17/23), and SP1633 (Exp. 4/21/23).
The lots were distributed throughout the United States.
Merck Sharp & Dohme initiated the recall December 21, 2020. On December 30, 2020, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Zerbaxa is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor. It is indicated for the treatment of adults with complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by designated susceptible microorganisms.