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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Merck Sharp & Dohme: Zerbaxa Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: December 29, 2020
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Summary

Merck Sharp & Dohme is recalling 106,503 vials of Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection. This voluntary recall was initiated because several batches of the medication failed sterility tests, with some testing positive for the bacterium Ralstonia pickettii. While the specific vials sold to the public met safety standards at the time of release, they were manufactured on the same equipment as the contaminated batches, creating a risk of infection.

Risk

If a patient receives a non-sterile injection contaminated with Ralstonia pickettii, it can lead to serious, life-threatening infections, especially in those with weakened immune systems or underlying health conditions. No injuries or specific patient infections have been reported to date for the distributed lots.

What You Should Do

  1. Check your medication packaging for Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection (NDC 67919-030-01).
  2. Verify if your product matches one of the following lot numbers and expiration dates: 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), or SP1633 (21-Apr-23).
  3. If you have an affected lot, stop using the medication immediately and contact your healthcare provider or pharmacist for medical guidance and to discuss alternative treatments.
  4. Return any unused vials to the pharmacy where they were purchased for a refund and contact Merck Sharp & Dohme at the Rahway, New Jersey facility for further product return instructions.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection
Model:
NDC 67919-030-01
Lot Numbers:
SP1488 (Exp 08-Jun-21)
SP1490 (Exp 11-Jun-21)
SP1492 (Exp 13-Jun-21)
SP1493 (Exp 15-Jun-21)
SP1494 (Exp 21-Jun-21)
SP1495 (Exp 23-Jun-21)
SP1496 (Exp 25-Jun-21)
SP1497 (Exp 27-Jun-21)
SP1498 (Exp 29-Jun-21)
SP1509 (Exp 20-Sep-21)
SP1510 (Exp 26-Sep-21)
SP1515 (Exp 16-Oct-21)
SP1517 (Exp 23-Oct-21)
SP1518 (Exp 25-Oct-21)
SP1519 (Exp 30-Oct-21)
SP1520 (Exp 01-Nov-21)
SP1521 (Exp 06-Nov-21)
SP1522 (Exp 08-Nov-21)
SP1523 (Exp 13-Nov-21)
SP1524 (Exp 15-Nov-21)
SP1525 (Exp 20-Nov-21)
SP1526 (Exp 27-Nov-21)
SP1537 (Exp 11-Jan-22)
SP1564 (Exp 17-Oct-22)
SP1567 (Exp 16-Oct-22)
SP1572 (Exp 24-Oct-22)
SP1573 (Exp 28-Oct-22)
SP1574 (Exp 29-Oct-22)
SP1584 (Exp 14-Nov-22)
SP1586 (Exp 15-Nov-22)
SP1588 (Exp 19-Nov-22)
SP1593 (Exp 03-Dec-22)
SP1602 (Exp 18-Dec-22)
SP1603 (Exp 19-Dec-22)
SP1606 (Exp 08-Jan-23)
SP1609 (Exp 15-Jan-23)
SP1610 (Exp 20-Jan-23)
SP1611 (Exp 22-Jan-23)
SP1626 (Exp 13-Apr-23)
SP1629 (Exp 17-Apr-23)
SP1633 (Exp 21-Apr-23)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87018
Status: Resolved
Manufacturer: Merck Sharp & Dohme
Manufactured In: United States
Units Affected: 106,503 vials
Distributed To: Nationwide
Agency Last Updated: January 7, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.