United States
East Windsor, New Jersey, Eugia US LLC (formerly AuroMedics Pharma LLC) has initiated a voluntary recall of lot number AC22006 of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single dose vial to the consumer level from the U.S. market due to a product complaint for the presence of a dark red, brown and black particulate inside the vial.
Risk Statement: 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 LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed for this lot.
AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), contains acyclovir, a synthetic nucleoside analog, active against herpes viruses. Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV- 1 and HSV-2) in immunocompromised patients and initial clinical episodes of herpes genitalis in immuno-competent patients. It is packaged in a glass vial labeled with NDC 55150-154-10. The lot being recalled is AC22006 with an expiration date of 08/2023. Eugia US LLC shipped the entire lot to wholesalers nationwide from June 8, 2022, through June 13, 2022.
The product label is as shown below: Eugia US LLC is notifying its direct consignees by recall letters and is arranging for return/ replacement of all recalled products. Wholesale customers and health professionals that have the product lot which is being recalled should immediately place the recalled lot on hold.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Eugia US LLC
Brand name: Auromedics
Product recalled: Acyclovir Intravenous Product
Reason of the recall: Presence of a dark red, brown and black particulate inside the vial
FDA Recall date: September 27, 2022
Source:
www.fda.gov
