# FDA recall D-0095-2019

> **Pfizer Inc.** · Class II · drug recall initiated 2018-09-20.

## Product

Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA.  NDC carton: 0409-3506-01; NDC vial: 0409-3506-11

## Reason for recall

Lack of assurance of sterility: loss of container integrity.

## Distribution

Nationwide in the US and Puerto Rico

## Key facts

- **Recall number:** D-0095-2019
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-20
- **Report date:** 2018-10-31
- **Termination date:** 2022-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2019

## Citation

> AI Analytics. FDA recall D-0095-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0095-2019. Source: US FDA. Licensed CC0.

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