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Class II: temporary or reversible health riskTerminated

Merck Sharp & Dohme Zerbaxa Recall

Zerbaxa (ceftolozane and tazobactam) 1

Merck Sharp & Dohme · Rahway, NJ

Risk level
Class II
Reported by FDA
Jan 13, 2021
Recall ID
D-0176-2021
Check your lot numberHow we source this data

Summary

Merck Sharp & Dohme recalled Zerbaxa starting Dec 21, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0176-2021 on Jan 13, 2021. Reason: 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. Status: Terminated.

Why it was recalled

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.

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

U.S.A. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0176-2021
Classification
Class II
Status
Terminated
Recall initiated
Dec 21, 2020
FDA report date
Jan 13, 2021
Quantity
106,503 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Merck Sharp & Dohme

Original FDA data

Every field from FDA enforcement report D-0176-2021, exactly as published.

Show all FDA fields
City
Rahway
State
NJ
Status
Terminated
Country
United States
Event ID
87018
Address
126 E Lincoln Ave
Code information
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
Postal code
07065-4607
Report date
Jan 13, 2021
Product type
Drugs
Recall number
D-0176-2021
Classification
Class II
Recalling firm
Merck Sharp & Dohme
Product quantity
106,503 vials
Termination date
Dec 4, 2023
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
U.S.A. Nationwide
Recall initiation date
Dec 21, 2020
Initial firm notification
Letter
Center classification date
Jan 7, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0176-2021, published Jan 13, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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