Ampicillin and Sulbactam for Injection Recalled Due to Sterility Concerns
Ampicillin and Sulbactam for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 58,770 vials manufactured by Astral SteriTech Private Ltd. are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involving a sterility assurance issue for an injectable antibiotic. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario that meets the rubric criterion for Score 3.
Plain-English summary
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, is being recalled nationwide. This is an injectable antibiotic combination used to treat bacterial infections. The product was manufactured by Astral SteriTech Private Ltd. and distributed by Piramal Critical Care in Bethlehem, Pennsylvania. Approximately 58,770 vials have been distributed.
The recall was initiated due to lack of assurance of sterility. This means the FDA cannot confirm that all affected vials meet sterility requirements and are safe for injection. Sterility is critical for injectable medications, as any contamination could present a potential risk to patients receiving the medication.
Healthcare facilities and providers that have received this product should immediately discontinue use of affected vials. The affected product NDC is 66794-241-41, and all lots within expiry are included in this recall. The FDA recall number is D-0596-2023.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 58,770
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.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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