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Apace Packaging LLC is voluntarily recalling acyclovir (Zovirax) tablets due to mislabeling concerns. This recall affects one lot of acyclovir 400 mg 50-count unit-dose packages (NDC 50268-061-15; Lot 19900). The NDC on the individual blister cards is 50268-061-11. This lot may contain torsemide 20 mg tablets, but is labeled as acyclovir 400 mg tablets. Acyclovir is an antiviral agent used to treat or prevent infections caused by certain viruses. Missing a dose of acyclovir could worsen the viral infection being treated. Torsemide is a loop diuretic used in the treatment of edema and hypertension. Unintentional exposure of torsemide could cause excessive urination and electrolyte complications associated with the loss of fluid.
Apace Packaging LLC has notified distributers and customers by email to arrange the return of the mislabeled lot. Consumers with questions regarding this recall may contact Apace Packaging by phone (270-434-2722). Consumers should report any adverse reactions experienced from this product to their provider and the FDA MedWatch Adverse Event Reporting Program.
Additional Information:
- MedWatch Safety Alert – February 13, 2018
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm596590.htm - Apace Packaging LLC press release – February 15, 2018
www.fda.gov/Safety/Recalls/ucm596505.htm