Astral SteriTech recalls 1.5g Ampicillin/Sulbactam injections due to lack of sterility assurance. All lots within expiry date are affected. Contact for return instructions.
Lack of Assurance of Sterility
Astral SteriTech is recalling Ampicillin and Sulbactam injections for potential contamination risks. This recall affects all vials produced by Piramal Critical Care in Bethlehem, PA, with no specific lot numbers listed.
The product lacks assurance of sterility, meaning it could become contaminated during manufacturing or storage. Contaminated injections may cause serious infections or other health complications if used.
Prescription patients using Ampicillin and Sulbactam injections for medical treatment. Healthcare providers administering these injections are most at risk due to potential contamination.
Check for vials labeled 'Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only'. The product was manufactured by Piramal Critical Care in Bethlehem, PA, with NDC 66794-206-41.
Verify the product label matches the recalled items: Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only.
The recall states there is a lack of assurance of sterility, so it may be contaminated. Do not use until contacted by the manufacturer.
The recall record does not specify replacement options or return procedures.
The product could become contaminated, leading to potential infections or health complications if used.
We’ve drafted a message you can send Astral SteriTech to request your refund or repair — edit it as you like.
Subject: Recall D-0595-2023 — Astral SteriTech Astral SteriTech Hello, I own a Astral SteriTech that is covered by recall D-0595-2023 from Astral SteriTech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
