D-1306-2020 Class II Terminated
FDA drug recall D-1306-2020 was initiated by Pfizer Inc. on May 29, 2020 and is designated Class II. Reason for recall: Presence of Particulate Matter: particulate matter identified after reconstitution. The recall status is terminated (terminated January 13, 2022). Affected quantity: 94320 units.
Recall Details
- Product Type
- Drugs
- Report Date
- June 17, 2020
- Initiation Date
- May 29, 2020
- Termination Date
- January 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94320 units
Product Description
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 Pattern
Distributed Nationwide in the US
Code Information
Lot # 3301612, EXP 02/2022