PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 13, 2021 Initiated: December 21, 2020 #D-0176-2021

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

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.

Details

Recalling Firm
Merck Sharp & Dohme
Units Affected
106,503 vials
Distribution
U.S.A. Nationwide
Location
Rahway, NJ

Frequently Asked Questions

What product 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. Recalled by Merck Sharp & Dohme. Units affected: 106,503 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 13, 2021. Severity: Moderate. Recall number: D-0176-2021.

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