Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up

AUDIENCE: Pharmacy, Patient

ISSUE: Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg Tablets.

Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated. Unintentional dosing of Torsemide, 20mg Tablets could cause excessive urination. Serious adverse events reported in the clinical studies, for which a drug relationship could not be excluded, were atrial fibrillation, chest pain, diarrhea, digitalis intoxication, gastrointestinal hemorrhage, hyperglycemia, hyperuricemia, hypokalemia, hypotension, hypovolemia, shunt thrombosis, rash, rectal bleeding, syncope, and ventricular tachycardia.

BACKGROUND: Acyclovir Tablet, USP, 400mg 50ct Unit Dose (NDC# 50268-061-15) is used for the acute treatment of herpes zoster (shingles), for the initial treatment and management of recurrent episodes of genital herpes, and for the treatment of chickenpox. Torsemide, 20mg Tablets are used for the treatment of edema and hypertension.

The affected lot of Acyclovir 400mg Tablet is Lot 19900 with an expiration date of 05/2019. The subject product was fully distributed to R&S Northeast, and then further distributed nationwide.

RECOMMENDATION: Apace Packaging LLC has notified its distributors and customers by email and is arranging for return of all recalled product. Distributors that have any of the subject product which is being recalled should contact Customer Service at AvKARE, Inc. at 931-292-6222 to arrange for the return of the product.

Consumers with questions regarding this recall can contact Apace Packaging by 270-434-2722 Monday-Friday (8am – 4pm CST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Healthcare 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: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm596590.htm