The Recall Desk
HighFDA (Drugs)·D-0585-2023·Announced 2023-05-24

Ampicillin for Injection Recalled Due to Lack of Sterility Assurance

Ampicillin for Injection, 250 mg per vial (NDC 70594-084-02) is recalled nationwide due to lack of assurance of sterility. The recall affects 53,220 vials manufactured by Astral SteriTech Private Ltd.

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 FDA Class II recall involves a manufacturing defect (lack of assurance of sterility) that poses a risk of serious harm including potential infection if the product is contaminated. However, no confirmed illnesses or hospitalizations are reported in the source, placing it at the 'High' severity level rather than 'Severe'.

Plain-English summary

Ampicillin for Injection, USP, 250 mg per vial (NDC 70594-084-02) manufactured by Astral SteriTech Private Ltd. for Xellia Pharmaceuticals USA, LLC, is being recalled due to lack of assurance of sterility.

The recall affects 53,220 vials that were distributed nationwide throughout the United States. All recalled lots remain within their expiration dates at the time of recall.

The lack of assurance of sterility indicates a manufacturing defect that could potentially compromise the safety and efficacy of the product. This is classified as a Class II recall by the FDA.

The recalled product

Product
Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Injectable Antibiotic
Hazard
  • sterility-defect

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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