Eugia US LLC Recalls Acyclovir Sodium Injection 500 mg per 10 mL
Medical Recalls
Acyclovir Sodium Injection 500 mg per 10 mL
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.
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.
Eugia US LLC is notifying its direct consignees by recall letters and is arranging for return/ replacement of all recalled product.
Source: FDA
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Consumer Contact: -
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 recall@qualanex.com (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 recall@qualanex.com), or their physician as appropriate.
Consumers with medical questions regarding this recall or to report an adverse event can contact the Drug Safety Department from 8:00 am to 5:00 pm M-F EST at:
- 1-866-850-2876 Option 2
- pvg@aurobindousa.com
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 recall@qualanex.com (live calls received 7:00 am to 4:00 pm M-F CST).
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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.
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Report a Problem With This Product
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
- Regular Mail or Fax: Download form 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
- Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
- https://www.fda.gov/safety/report-problem-fda
- Call an FDA Consumer Complaint Coordinator.
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