FDA recall D-0176-2021

Product

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

Reason for recall

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.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-21

Report date

2021-01-13

Termination date

2023-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rahway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0176-2021