Merck Sharp & Dohme: Drug Recall
Recall #D-0176-2021 · 12/21/2020
Class II: Risk
Recall Details
- Recall Number
- D-0176-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Merck Sharp & Dohme
- Status
- Terminated
- Date Initiated
- 12/21/2020
- Location
- Rahway, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106,503 vials
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.
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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.