Drug Safety Alerts

Acyclovir Sodium Injection Class I Recall

4/7/2021

On April 7, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of Acyclovir Sodium Injection distributed by Zydus Pharmaceuticals. This recall was issued due to customer complaints of crystallization in the finished product.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

A complete list of the affected products and lot numbers is provided here.

Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential for serious adverse consequences including local reactions at the injection site and injection site inflammation of a vein. Potential life-threatening consequences can also occur, including damage and/or obstruction of blood vessels and the passage of the particulate matter into the bloodstream, both of which could induce clots in the lungs, clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells. To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall.

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.

Patients should not use drug that is affected by this recall. Patients are advised to call their doctor right away for advice if they might be using affected drug.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall, please call Zydus Pharmaceuticals (USA) Inc. toll-free at 1-877-993-8779. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.accessdata.fda.gov and https://www.accessdata.fda.gov.