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February 15, 2018: Apace Packaging Issues Acyclovir Recall For Product Mix-Up

Apace Packaging Announces Acyclovir Recall – On February 15, 2018, Apace Packaging LLC issued a recall for one lot of Acyclovir Tablets due to a product mix-up. According to the company announcement, blister cards containing Acyclovir (400 mg) Tablets may also include Torsemide (200 mg) Tablets.

Acyclovir Recall – Product Information

Product covered by the Acyclovir Recall can be identified as follows:

Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15 (Carton), NDC# 50268-061-11 (Blister Card), Lot Number 19900, to the Retail level.

The Apace Packaging recall announcement stated:

“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. To date, Apace Packaging LLC has not received any reports of adverse events related to this recall. Acyclovir Tablet, USP, 400mg 50ct Unit Dose (NDC# 50268-061-15/50268-061-11) 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 product is packaged in 50-count hospital unit dose cartons (10 unit doses per card, 5 cards per carton). 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.”

Apace Packaging reported that the company has notified its distributors and customers by email and is arranging for return of all recalled product. The company also stated that recall was reported to the U.S. Food and Drug Administration (FDA).

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