AuroMedics Pharma recalls Acyclovir Sodium Injection vials due to dark red, brown, and black particulate matter found in the product. This may cause injury if injected.
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
AuroMedics Pharma is recalling Acyclovir Sodium Injection vials after customer reports of dark red, brown, and black particles floating inside the vials. This particulate matter could cause injury if the injection is administered.
The vials contain visible dark red, brown, and black particles that could be injected into the body. This particulate matter may cause injury or irritation if the injection is administered.
Patients prescribed Acyclovir Sodium Injection by a healthcare provider. Those using the product in the United States are most at risk.
Check for vials labeled 'Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only'. The product was distributed by AuroMedics Pharma LLC in the US and made in India with NDC 55150-154-10.
Inspect the vial for dark red, brown, or black particles floating inside.
The recall is due to customer reports of visible particles in the vial. If particles are present, do not use the product.
Look for vials labeled 'Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only' with NDC 55150-154-10.
Check the vial for particles. If particles are visible, do not use the product.
We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.
Subject: Recall D-0013-2023 — AuroMedics AuroMedics Hello, I own a AuroMedics that is covered by recall D-0013-2023 from AuroMedics. 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.
