Drug recall D-1306-2020
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.
Lots and codes
Lot # 3301612, EXP 02/2022
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 94320 units
- Distribution
- Distributed Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 29, 2020
- Terminated
- January 13, 2022
Related products
- Unasyn – drug information
- NDC 0049-0014 Unasyn · Ampicillin Sodium 2 g/1; Sulbactam Sodium 1 g/1 · Roerig
- NDC 0049-0013 Unasyn · Ampicillin Sodium 1 g/1; Sulbactam Sodium .5 g/1 · Roerig