Reported Jun 17, 2020 · Terminated

Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy…

Pfizer Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pfizer Inc. · 235 E 42nd St · New York, NY · 10017-5703

Is this the product you have?

  • 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
Lot codes and dates
    • Lot # 3301612
    • EXP 02/2022
Amount recalled
94320 units

Where it was sold

  • Nationwide

Why it was recalled

Presence of Particulate Matter: particulate matter identified after reconstitution.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 13, 2022 · Data as of Sep 19, 6:26 PM UTC

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