The Recall Desk
HighFDA (Drugs)·D-0586-2023·Announced 2023-05-24

Ampicillin for Injection Recalled Due to Sterility Assurance Concerns

Ampicillin for Injection (500 mg/vial) is being recalled nationwide due to inability to assure sterility. The recall covers approximately 59,530 vials.

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 with no reported illnesses or injuries. It involves a risk-of-harm product (injectable medication) where sterility assurance is lacking, but no patient harm has been documented.

Plain-English summary

Ampicillin for Injection, USP 500 mg per vial (NDC 70594-085-02) is being recalled. The product is manufactured by Astral SteriTech Private Ltd. for Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL. Approximately 59,530 vials of all lots remaining within expiration date have been distributed nationwide within the United States.

The recall is being issued due to lack of assurance of sterility. The manufacturer cannot confirm that this injectable antibiotic product meets required sterility standards.

The recalled product

Product
Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
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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