Astral SteriTech recalls Ampicillin and Sulbactam injections due to potential lack of sterility. This could cause infections if used improperly. Affected units include specific NDC numbers and lots within expiry dates.
Lack of Assurance of Sterility
Astral SteriTech is recalling Ampicillin and Sulbactam injections that may not be sterile, which could lead to infections if used. This recall affects specific vial sizes and lots produced for medical use.
The injections may not be sterile, which could lead to infections if the product is used. This risk is specific to medical use under a doctor's supervision.
Healthcare providers and patients prescribed this medication by a doctor. Those using the product without medical supervision are not affected.
Check for vials labeled 'Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only'. The product was manufactured by Xellia Pharmaceuticals USA, LLC in Buffalo Grove, IL with NDC 70594-082-02. All lots within expiry dates are affected.
Look for the NDC number 70594-082-02 on the vial label.
The product may not be sterile, which could cause infections. It is not safe for use without medical supervision.
Check for vials labeled 'Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only' with NDC 70594-082-02.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Astral SteriTech to request your refund or repair — edit it as you like.
Subject: Recall D-0602-2023 — Astral SteriTech Astral SteriTech Hello, I own a Astral SteriTech that is covered by recall D-0602-2023 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.
