The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0176-2021·Announced 2021-01-13

Merck Recalls Zerbaxa Injection Vials Due to Sterility Test Failures

Merck Sharp & Dohme is recalling 106,503 vials of Zerbaxa (ceftolozane and tazobactam) injection because sterility tests on related batches failed.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a sterile injectable drug with sterility test failures, including positive results for Ralstonia pickettii, which poses a significant risk of infection.

Plain-English summary

Merck Sharp & Dohme is recalling 106,503 vials of Zerbaxa (ceftolozane and tazobactam) 1.5g for injection. The product is distributed nationwide in the U.S. and is available by prescription only. The recall covers specific lots with expiration dates ranging from June 2021 to April 2023.

The recall was initiated due to a lack of assurance of sterility. Sterility tests for seven batches of the 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. Although the product distributed to the market met registered specifications for release, including sterility, it was manufactured on the same equipment as the affected batches.

Healthcare providers and patients should discontinue use of the affected lots. Consumers should check their medication vials against the lot numbers and expiration dates listed in the official recall notice to determine if they are affected.

The recalled product

Product
ZERBAXA (CEFTOLOZANE AND TAZOBACTAM)
Brand
ZERBAXA
Manufacturer
Merck Sharp & Dohme
Category
Drug — Antibiotic Injection
Hazard
Affected units
106,503

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All lots within expiry: SP1488 08-Jun-21
  • SP1490 11-Jun-21
  • SP1492 13-Jun-21
  • SP1493 15-Jun-21
  • SP1494 21-Jun-21
  • SP1495 23-Jun-21
  • SP1496 25-Jun-21
  • SP1497 27-Jun-21
  • SP1498 29-Jun-21
  • SP1509 20-Sep-21
  • SP1510 26-Sep-21
  • SP1515 16-Oct-21
  • SP1517 23-Oct-21
  • SP1518 25-Oct-21
  • SP1519 30-Oct-21
  • SP1520 01-Nov-21
  • SP1521 06-Nov-21
  • SP1522 08-Nov-21
  • SP1523
  • 13-Nov-21

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · sterility failure

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