The Recall Desk
HighFDA (Drugs)·D-0582-2023·Announced 2023-05-24

Ampicillin Injection Vials Recalled for Sterility Assurance Failure

Astral SteriTech is recalling approximately 89,690 vials of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide.

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: FDA Class II recall for injectable drug product lacking sterility assurance. No illnesses or injuries have been reported. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Astral SteriTech Private Ltd. is recalling approximately 89,690 vials of Ampicillin for Injection, USP 1g per vial (NDC 66794-222-41), manufactured for Piramal Critical Care, due to lack of assurance of sterility.

The affected vials were distributed nationwide within the United States. Sterility is critical for injectable medications, and failure to ensure sterile conditions creates a risk of microbial contamination.

Patients and healthcare providers who have received or are currently using affected vials should consult with their healthcare provider or pharmacist regarding their treatment.

The recalled product

Product
Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Injectable Antibiotic
Hazard
  • lack-of-sterility
  • contamination-risk

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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