On March 25, 2021, the U.S. Food and Drug Administration (FDA) shared Zydus Pharmaceuticals Inc.’s notice of its voluntary recall of four lots of acyclovir sodium injection 50 mg/ml, supplied in 10 ml and 20 ml vials, after receiving reports of crystallization in the product.

“Administration of crystalized acyclovir sodium injection has a potential to cause 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 that may also lead to clots, resulting in stroke, heart attack, decreased liver or kidney function, or death of tissues or cells,” Zydus Pharmaceuticals Inc. advised. To date, the company has not received any reports of adverse events related to the 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. The product is packaged in single-dose glass vials and was distributed across the United States to Cardinal Health, Amerisourcebergen Drug Corporation, and Morris and Dickson Company LLC. The following lots are affected:

Product

Carton NDC Number

Vial NDC Number

Lot Number

Expiration Date

Acyclovir sodium injection
50 mg/ml, 10 x 20 ml single-dose pack

68382-049-10

68382-049-01

L000155

Dec 2021

Acyclovir sodium injection
50 mg/ml, 10 x 20 ml single-dose pack

68382-049-10

68382-049-01

L000156

Jan 2022

Acyclovir sodium injection
50 mg/ml, 10 x 10 ml single-dose pack

68382-048-10

68382-048-01

L000126

Dec 2021

Acyclovir sodium injection
50 mg/ml, 10 x 10 ml single-dose pack

68382-048-10

68382-048-01

L000127

Dec 2021

Zydus Pharmaceuticals Inc. has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled lots. Hospitals should stop using the recalled lots immediately and contact the company’s recall coordinating center at 855-671-5023, Monday–Friday from 9 am–5 pm EST.

Patients with questions about the recall can contact Zydus Pharmaceuticals Inc. by phone (877-993-8779) or email, Monday–Friday from 9 am–5 pm EST. Patients should contact their physician or healthcare provider if they experience any problems that may be related to the drug product.

Report any adverse reactions or quality problems experienced with the use of the product to FDA’s MedWatch adverse event reporting program either online or by regular mail or fax.