FDAFDA · Food and drugs·Recall number D-1306-2020
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
Published June 17, 2020 · Recall initiated: May 29, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: particulate matter identified after reconstitution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- UNASYN
- Manufacturer
- Pfizer Inc.
- Distributor
- Distributed Nationwide in the US
- Lot
- Lot # 3301612, EXP 02/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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