Zerbaxa per vial for injection recalled over sterility concerns

Recall date

December 21, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Merck Sharp & Dohme recalls Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp &…

Recall number

D-0176-2021

FDA classification

Class II

Brand / firm

Merck Sharp & Dohme

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01