Eugia US LLC puts a voluntary recall on Acyclovir Sodium Injection 500 mg per lot number AC22006 due to the presence of particulates. This recall is being made with the knowledge of the U.S. Food and Drug Administration (FDA).
The recall is in response to complaints of the presence of dark red, brown, and/or black particulates in the Acyclovir Sodium Injection 500 mg per. The consumer-level recall is being initiated because Eugia US LLC has determined that the particulates may present a safety hazard to patients.
Risk Statement
The administration of parenteral drug products that contain particulate matter could result in local irritation, inflammation, or blockage if injected. These effects could be life-threatening or result in long-term adverse events. To date, Eugia US LLC has not received any reports of adverse events related to this recall.
AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL) is used to treat infections caused by the herpes simplex virus, such as:
- Herpes simplex encephalitis
- Mucocutaneous herpes simplex virus infections in immunocompromised patients
- Herpes zoster (shingles)
- Genital herpes simplex virus infections in immunocompetent and immunocompromised patients
- Varicella zoster virus infections in immunocompromised children
It contains the active ingredient Acyclovir Sodium, which is a synthetic nucleoside analog active against herpes viruses.
Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL) is packed in a glass vial supplied as – NDC 55150-154-10 in 25 count cartons.
Eugia US LLC shipped the entire lot AC22006 to Wholesalers/Distributors nationwide on June 8, 2022, through June 13, 2022. The lot has an expiry date of August 2023.
The Product Label
Eugia US LLC issued the recall notification through letters and is making arrangements to receive and replace all recalled products.
The letters were sent to the Wholesalers/Distributors notifying them of the recall and requesting that they notify their customers. Any wholesalers or health professionals in possession of the product lot are now requested to put the product distribution on hold and call Qualanex at 1-888-280-2046 or email [email protected].
Customers who have any of the affected products are urged not to consume them and to return them to the place of purchase or call their physicians. They can also contact Qualanex at 1-888-280-2046 or email [email protected].
Consumers who have experienced the symptoms described above after using this product can report to FDA’s MedWatch Adverse Event Reporting program. You can do this in two ways:
- Fill and submit the form online through www.fda.gov/medwatch/report.htm
- Use regular mail to www.fda.gov/MedWatch/getforms.htm or request a reporting form at 1-800-332-1088
- Or by fax at 1-800-FDA-0178.
Eugia US LLC has made the recall with the full knowledge of the U.S Food and Drug Administration (FDA).
