Eugia US LLC, formerly AuroMedics Pharma LLC, has initiated a recall of certain AuroMedics Acyclovir Sodium Injection from the U.S. market citing the presence of a dark red, brown and black particulate inside the vial, the U.S. Food and Drug Administration said.
AuroMedics Acyclovir Sodium Injection contains acyclovir, a synthetic nucleoside analog, active against herpes viruses. The drug is 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.
The recall involves 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 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.
The recall was initiated following a product complaint for the presence of a dark red, brown and black particulate inside the vial.
The agency noted that the administration of an intravenous product containing particulates may result in inflammation, allergic reactions, or circulatory system complications that could be life-threatening.
However, the East Windsor, New Jersey-based company has not received reports of any adverse events or identifiable safety concerns related to the recalled product to date.
Eugia US is notifying its direct consignees by recall letters and is arranging for return/ replacement of all recalled product. Wholesale customers and health professionals are asked to immediately place the recalled lot on hold.
Consumers are asked to contact their physician or healthcare provider for any problems likely related to taking or using the affected drug product.
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