# FDA recall D-1306-2020

> **Pfizer Inc.** · Class II · drug recall initiated 2020-05-29.

## Product

Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83

## Reason for recall

Presence of Particulate Matter: particulate matter identified after reconstitution.

## Distribution

Distributed Nationwide in the US

## Key facts

- **Recall number:** D-1306-2020
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-05-29
- **Report date:** 2020-06-17
- **Termination date:** 2022-01-13

- **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-1306-2020

## Citation

> AI Analytics. FDA recall D-1306-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1306-2020. Source: US FDA. Licensed CC0.

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