# FDA recall D-0176-2021

> **Merck Sharp & Dohme** · Class II · drug recall initiated 2020-12-21.

## 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

- **Recall number:** D-0176-2021
- **Recalling firm:** Merck Sharp & Dohme
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0176-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0176-2021. Source: US FDA. Licensed CC0.

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