On September 27, 2022, the U.S. Food and Drug Administration (FDA) reported Eugia US, LLC’s, voluntary recall of AuroMedics acyclovir sodium injection 500 mg per 10 ml (50 mg/ml) single-dose vial to the consumer level because of reported presence of a dark red, brown, and black particulate inside the vial.
In the recall, Eugia US, LLC, advised that administration of an IV product containing particulates can result in inflammation, allergic reactions, or life-threatening circulatory system complications. To date, Eugia US, LLC, has not received reports any adverse events or identifiable safety concerns related to the recall.
The affected lot’s number is AC22006 with an expiration date of 08/2023. Eugia US, LLC, shipped the lot to wholesalers nationwide from June 8–13, 2022.
FDA said that Eugia US, LLC, notified consumers in writing and is arranging for return of the affected product.
Wholesale customers and healthcare professionals that have products from the recalled lot should immediately place the lot on hold and contact Qualanex at 888-280-2046 Monday–Friday, from 7 am–4 pm CST, or email recall@qualanex.com.
FDA reported that Eugia US, LLC, recommended consumers who have products from the recalled lot contact Qualanex at 888-280-2046 or email recall@qualanex.com. Consumers should contact their healthcare provider if they experienced any problems that may be related to taking or using the recalled product.
Consumers with medical questions regarding this recall or wanting to report an adverse event can contact Eugia US, LLC’s, drug safety department at 866-850-2876 Monday–Friday, from 8 am–5 pm EST, or email pvg@aurobindousa.com.
Contact Qualanex at 888-280-2046 Monday–Friday, from 7 am–4 pm CST, or email recall@qualanex.com, with general questions regarding the product’s return.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.