FDA Recall Zerbaxa

The most recent Recall Enforcement Report that covers this product was initiated on December 21st, 2020 and classified as a Class II recall due to lack of assurance of sterility: the results of sterility tests of seven batches of product were out of specification. five of these batches tested positive for ralstonia pickettii and two batches produced turbid results that could not be further identified. while all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches. This recall is currently terminated, and the associated recall number is recall number is D-0176-2021. It pertains to Zerbaxa identified by 67919-030 as of 12-04-2023 .

Recall Number D-0176-2021

Event ID

87018 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-0176-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".

Distribution Pattern

U.S.A. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

Product Description

Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01

Reason For Recall

Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches. What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

106,503 vials Product Quantity
The amount of product subject to recall.

Voluntary Mandated

Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.

Report Date

01-13-2021

Recall Initiation Date

12-21-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Termination Date

12-04-2023 What is the Date Terminated?
The date that FDA terminated the recall.

Initial Firm Notification

Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.

Product Type

Drugs

Recalling Firm

Merck Sharp & Dohme

Code Info/dt>

All lots within expiry: SP1488 08-Jun-21; SP1490 11-Jun-21; SP1492 13-Jun-21; SP1493 15-Jun-21; SP1494 21-Jun-21; SP1495 23-Jun-21; SP1496 25-Jun-21; SP1497 27-Jun-21; SP1498 29-Jun-21; SP1509 20-Sep-21; SP1510 26-Sep-21; SP1515 16-Oct-21; SP1517 23-Oct-21; SP1518 25-Oct-21; SP1519 30-Oct-21; SP1520 01-Nov-21; SP1521 06-Nov-21; SP1522 08-Nov-21; SP1523;13-Nov-21; SP1524; 15-Nov-21; SP1525 20-Nov-21; SP1526 27-Nov-21; SP1537 11-Jan-22; SP1564 17-Oct-22; SP1567 16-Oct-22; SP1572 24-Oct-22; SP1573; 28-Oct-22; SP1574 29-Oct-22; SP1584; 14-Nov-22; SP1586; 15-Nov-22; SP1588; 19-Nov-22; SP1593 03-Dec-22; SP1602 18-Dec-22; SP1603; 19-Dec-22; SP1606 08-Jan-23; SP1609 15-Jan-23; SP1610 20-Jan-23; SP1611 22-Jan-23; SP1626 13-Apr-23; SP1629 17-Apr-23; SP1633 21-Apr-23 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Recalled NDC Packages

67919-030-01

Status

Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.