The Recall Desk
HighFDA (Drugs)·D-0590-2023·Announced 2023-05-24

Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Failure

Astral SteriTech is recalling 59,040 vials of Ampicillin and Sulbactam 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: This is an FDA Class II recall for a sterility assurance failure in an injectable medication. While no illnesses or deaths have been reported, lack of sterile assurance in injectable drugs poses a theoretical risk of serious infection, meeting the criterion for High severity.

Plain-English summary

Astral SteriTech Private Ltd. is recalling Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial (NDC 72572-021-10). The recall involves 59,040 vials that were distributed nationwide within the United States.

The FDA Class II recall was initiated due to lack of assurance of sterility in the affected product. All lots within their expiry period are included in the recall.

Patients and healthcare providers who have the affected medication should consult their healthcare provider or pharmacist for guidance on treatment alternatives.

The recalled product

Product
Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10
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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