- Company Announcement Date:
- September 27, 2022
- FDA Publish Date:
- September 27, 2022
- Product Type:
- Reason for Announcement:
Recall Reason Description
Presence of a dark red, brown and black particulate inside the vial
- Company Name:
- Eugia US LLC
- Brand Name:
- Product Description:
Acyclovir Intravenous Product
FOR IMMEDIATE RELEASE – September 26, 2022– 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 product. Wholesale customers and health professionals that have the product lot which is being recalled should immediately place the recalled lot on hold and contact Qualanex at 1-888-280-2046 or email recal[email protected] (live calls received 7:00 am to 4:00 pm M-F CST).
Patients / consumers that have the product lot which is being recalled should contact Qualanex (telephone 1-888-280-2046 or email [email protected]), or their physician as appropriate.
Consumers with medical questions regarding this recall or to report an adverse event can contact our Drug Safety Department from 8:00 am to 5:00 pm M-F EST at:
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.
General questions regarding the return of this product should be directed to Qualanex at 1-888-280-2046 or email [email protected] (live calls received 7:00 am to 4:00 pm M-F CST).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.