FDA MedWatch – Acyclovir Sodium Injection, 50 mg/mL by Zydus Pharmaceuticals: Recall

TOPIC: Acyclovir Sodium Injection, 50 mg/mL by Zydus Pharmaceuticals: Recall – Due to Crystallization

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy

ISSUE: Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells.

To date, Zydus Pharmaceuticals has not received any reports of adverse events related to this product recall.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: Acyclovir Sodium Injection, 50 mg/mL is indicated for the treatment of herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster (shingles) infections in immunocompromised patients.

RECOMMENDATIONS: 

• Hospitals that have the product which is being recalled should stop using it immediately.
• 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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.