The Recall Desk
HighFDA (Drugs)·D-0601-2023·Announced 2023-05-24

Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Defect

The FDA has recalled Ampicillin and Sulbactam for Injection due to lack of assured sterility. Approximately 119,340 vials distributed nationwide within the United States are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall for an injectable medication with a potential sterility defect. With no illnesses or injuries reported in the source material, the hazard is theoretical, placing it at Score 3 (High) per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Astral SteriTech Private Ltd., manufacturing for Xellia Pharmaceuticals USA, LLC, has recalled Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial due to lack of assured sterility. Approximately 119,340 vials were distributed nationwide within the United States, with all lots currently within their expiration dates included in the recall.

The product is identified by NDC number 70594-081-02. The FDA issued this Class II recall to address the potential sterility defect. Additional information is available through the FDA's drug safety and recall database.

The recalled product

Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Injectable Antibiotic
Hazard
  • lack-of-sterility

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 (1)

  • All lots within expiry.

Distribution

Distributed nationwide across the United States.

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