Reported Jan 13, 2021 · Terminated
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp &…
Merck Sharp & Dohme
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merck Sharp & Dohme · 126 E Lincoln Ave · Rahway, NJ · 07065-4607
Is this the product you have?
- Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf
- forMerck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01
- Lot codes and dates
48 of 48 products
Products covered by this recall # Product as published 1 SP1488 08-Jun-21 2 SP1490 11-Jun-21 3 SP1492 13-Jun-21 4 SP1493 15-Jun-21 5 SP1494 21-Jun-21 6 SP1495 23-Jun-21 7 SP1496 25-Jun-21 8 SP1497 27-Jun-21 9 SP1498 29-Jun-21 10 SP1509 20-Sep-21 11 SP1510 26-Sep-21 12 SP1515 16-Oct-21 13 SP1517 23-Oct-21 14 SP1518 25-Oct-21 15 SP1519 30-Oct-21 16 SP1520 01-Nov-21 17 SP1521 06-Nov-21 18 SP1522 08-Nov-21 19 SP1523 20 13-Nov-21 - Amount recalled
- 106,503 vials
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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