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Class I Recall for Injection


April 07, 2021

Customer reports of product crystallization have prompted a Class I recall of four lots of acyclovir sodium injection. According to the April 7, 2021, US Food and Drug Administration (FDA) Enforcement Report, the medication was distributed throughout the United States by Zydus Pharmaceuticals (USA) Inc. 

The recall affects the following products, which were manufactured by Cadila Healthcare Ltd., Vadodara, India, and distributed nationwide by Zydus Pharmaceuticals (USA), Pennington, NJ, to Cardinal Health, AmerisourceBergen Drug Corporation, and Morris & Dickson Company:

  • acyclovir sodium injection 1000 mg/20 mL (50 mg/mL) for intravenous infusion only, packaged in 10 x 20-mL single-dose vials per pack (NDC 68382-049-01), from lots L000155 (Exp. 12/21) and L000156 (Exp. 1/22); and
  • acyclovir sodium injection 500 mg/10 mL (50 mg/mL) for intravenous infusion only, packaged in 10 x 10-mL single-dose vials per pack (NDC 68382-048-01), from lots L000126 and L000127 (Exp. 12/21).

The most serious of FDA recall classes, a Class I recall warns that use of the affected product could cause serious adverse health consequences or death.

“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,” Zydus Pharmaceuticals stated in a March 24, 2021, announcement. “To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall.”

Zydus Pharmaceuticals voluntarily initiated the recall February 18, 2021. On March 30, 2021, the FDA categorized the recall Class I. 

Acyclovir sodium injection is a prescription medication 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 shingles infections in immunocompromised patients. 

Jolynn Tumolo

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