Unasyn Injection, Powder, For Solution
FDA Recall NDC 0049-0013
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Unasyn (NDC 0049-0013). A significant event, classified as Class II, was initiated on May 29, 2020 by Roerig. The reported reason for this action was: "Presence of Particulate Matter: particulate matter identified after reconstitution."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: particulate matter identified after reconstitution.
May 29, 2020
Jun 17, 2020
94320 units
Recall Profile & Regulatory Data
Event ID
85754
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Jan 13, 2022
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
Batch or Lot Expiration Information
Lot# 3301612, EXP 02/2022
Affected Packages Involved in this Recall
0049-0013-81Product
0049-0013-83Product
0049-0014-81Product
0049-0014-83Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
