Merck Sharp & Dohme Recall: Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injecti
Merck Sharp & Dohme Recall: Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injecti is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Merck Sharp & Dohme; Product: Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp
| Recalling firm | Merck Sharp & Dohme |
|---|---|
| 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 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | U.S.A. Nationwide |
| Recall initiated | 20201221 |
| Recall number | D-0176-2021 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
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