Dark red, brown and black particulates were seen inside of one vial. Acyclovir is used to treat genital herpes and shingles.
Eugia US (formerly AuroMedics Pharma) has initiated a voluntary recall of one lot of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single dose vial. The recall was made because of the presence of a dark red, brown and black particulate inside a vial.
The administration of an intravenous product containing particulates has the potential to result in inflammation, allergic reactions, or circulatory system complications which could be life-threatening. To date, Eugia US has not received reports of any adverse events or identifiable safety concerns attributed to the product.
AuroMedics Acyclovir Sodium Injection is a synthetic nucleoside analog, active against herpes viruses. Acyclovir Sodium Injection is indicated to treat initial and recurrent herpes virus infections, including shingles and genital herpes.
The lot being recalled is AC22006 with an expiration date of 08/2023. It is packaged in a glass vial labeled with NDC 55150-154-10. Eugia US shipped the entire lot to wholesalers nationwide from June 8, 2022, through June 13, 2022.