The Recall Desk
HighFDA (Drugs)·D-0588-2023·Announced 2023-05-24

Ampicillin for Injection Recalled for Lack of Sterility Assurance

Ampicillin for Injection is being recalled by Xellia Pharmaceuticals because the manufacturer cannot assure the vials are sterile. The nationwide recall involves 220,340 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 for lack of sterility assurance in an injectable antibiotic. Per the severity rubric, a risk-of-harm product without reported injury is classified as High. Injectable drugs with potential contamination present serious risk to patient safety.

Plain-English summary

Xellia Pharmaceuticals USA, LLC is recalling Ampicillin for Injection, USP 2 g per vial (NDC 70594-087-02), manufactured by Astral SteriTech Private Ltd. The recall was initiated because the manufacturer cannot assure that all vials meet sterility standards.

Ampicillin for Injection is an antibiotic administered by injection. The recall affects 220,340 vials distributed nationwide throughout the United States, including all lots currently within their expiration dates. The FDA has classified this as a Class II recall.

The recalled product

Product
Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Injectable Antibiotic
Hazard
  • lack-of-sterility
  • contamination

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.

Related recalls

Same category