Recall Enforment Report D-0176-2021

Drug Recall Enforcement Report Class II voluntary initiated by Merck Sharp & Dohme, originally initiated on 12-21-2020 for the product 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 The product was recalled 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.. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
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	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.

Recalled Products