Recalls / Class II
Class IID-0176-2021
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
- Brand name
- Zerbaxa
- Generic name
- Ceftolozane And Tazobactam
- Active ingredients
- Ceftolozane Sulfate, Tazobactam Sodium
- Route
- Intravenous
- NDC
- 67919-030
- FDA application
- NDA206829
- Affected lot / 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
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.
Recalling firm
- Firm
- Merck Sharp & Dohme
- Manufacturer
- Merck Sharp & Dohme LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 126 E Lincoln Ave, Rahway, New Jersey 07065-4607
Distribution
- Quantity
- 106,503 vials
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-12-21
- FDA classified
- 2021-01-07
- Posted by FDA
- 2021-01-13
- Terminated
- 2023-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0176-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.