The Recall Desk
HighFDA (Drugs)·D-0599-2023·Announced 2023-05-24

Ampicillin and Sulbactam for Injection Recalled for Sterility Assurance Issue

Astral SteriTech has recalled Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. The recall affects 6,127 bottles.

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 drug recall involving lack of sterility assurance for an injectable antibiotic. No illnesses or hospitalizations have been reported. The hazard is a risk-of-harm scenario where injury has not yet been reported.

Plain-English summary

Astral SteriTech Private Ltd. has recalled Ampicillin and Sulbactam for Injection, USP (15 grams per Pharmacy Bulk Package), because the manufacturer cannot assure the product meets sterility requirements.

The recall affects 6,127 bottles distributed nationwide within the United States. All affected lots remain within their expiration dates. The product is manufactured for Piramal Critical Care, located in Bethlehem, Pennsylvania.

Ampicillin and Sulbactam for Injection is a combination antibiotic used in clinical settings. Sterility is a critical requirement for injectable medications. This recall addresses failures in the assurance of sterility.

The recalled product

Product
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15
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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