The Recall Desk
HighFDA (Drugs)·D-0602-2023·Announced 2023-05-24

Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Deficiency

Ampicillin and Sulbactam for Injection is being recalled nationwide because the manufacturer cannot assure sterility of 591,160 vials distributed throughout the United States.

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 an FDA Class II recall for a sterility assurance issue with no reported illnesses. The injectable nature of this antibiotic product represents a potential risk of harm, but absent hospitalization reports, the severity is High rather than Severe.

Plain-English summary

Ampicillin and Sulbactam for Injection, USP 3 grams per vial (NDC 70594-082-02), is being recalled due to a lack of assurance of sterility. The product was manufactured by Astral SteriTech Private Ltd. for Xellia Pharmaceuticals USA, LLC, and distributed nationwide throughout the United States.

Approximately 591,160 vials have been distributed. The recall affects all lots of this product remaining within their expiration date. The FDA has classified this as a Class II recall.

Patients and healthcare providers with questions should contact the manufacturer or their healthcare provider regarding this recall.

The recalled product

Product
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Injectable
Hazard
  • lack-of-sterility-assurance

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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