Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Zerbaxa (ceftolozane and tazobactam)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
67919-0030-01
Compare with the code on your package — it is the most precise check available.
Drug: Tazobactam
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zerbaxa ceftolozane and tazobactam NDC 67919-0030 |
CEFTOLOZANE SULFATE 1 g/10mL; TAZOBACTAM SODIUM .5 g/10mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Merck Sharp & Dohme LLC | Rx |
- Recalling firm
- Merck Sharp & Dohme
- NDC code
- 67919-030-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0176-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tazobactam recalls
See all
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
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