Last Updated on October 15, 2024 by The Health Master
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 vials to the consumer level in the U.S. market.
This product was recalled due to a product complaint for the presence of 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 that 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 immunocompetent 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
Drug recall: Zydus, Lupin recall products due to this issue
Drug recall: Glenmark, Strides Pharma, Cipla recalled these drugs
Drug recall: Glenmark, Sun, Dr Reddy’s recalled these Drugs
Drug recall: Atorvastatin 40 mg tablets recalled due to this reason
Drug recall: Magnesium Citrate Oral Solution recalled due to this reason
Drug recall: Propofol Injectable Emulsion recalled due to this reason
FDA J&K suspended licenses of Medicals Stores & Pharma Dealers
J & J appeals to Maharashtra FDA minister to revoke cancellation of license
IPGA Tamil Nadu Branch Celebrates World Pharmacists Day
Changing the Regulations for Class A Medical Devices and its Impact
Govt plan to ban Codeine based cough syrups opposed by Pharma companies
Cancer medicines may get cheaper
CDSCO Panel gives nod for FDC Bempedoic Acid Plus Atorvastatin Calcium
Pharmacists – The Doctors behind the screens
High Court quashes four demand notices of NPPA on overcharging
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
