Drug 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
D-1306-2020
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 85754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94320 units
- Official record key
drug-enforcement:D-1306-2020
Official wording
Reason: Presence of Particulate Matter: particulate matter identified after reconstitution.
Code information: Lot # 3301612, EXP 02/2022
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter