Apace Packaging LLC has issued a nationwide voluntary recall of one lot of the antiviral medication acyclovir due to a product mix-up. Acyclovir is a widely used medication prescribed to treat several infections, notably infections caused by the herpes virus, such as genital herpes, cold sores, shingles and chicken pox.
At this time, there have been no reports of adverse events as a result of the recall. The US Food and Drug Administration (FDA) has overseen ten drug recalls so far in 2018. Recalls are classified as Class I, II, or III, with Class I considered the most serious, posing a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”.
What was recalled?
One lot of acyclovir 400mg tablets in blister cards was recalled by Apace Packaging with the knowledge of the FDA. The affected medication was packaged in 50-count hospital unit dose cartons, with ten-unit doses on each card, and five cards per carton.
- Affected Drugs: Acyclovir 400mg tablets
- Lot: 19900, expires 05/2019
- Manufacturer: AvKARE Pharmaceuticals
- NDC: cartons: 50268-061-15, blister cards: 50268-061-11
Why was it recalled?
A small number of the blister cards could contain 20mg tablets of the loop diuretic drug torsemide, rather than acyclovir. Torsemide is used to treat fluid retention (edema) in patients with congestive heart failure, kidney disease, kidney failure or liver disease.
There is a possibility that missing a dose of acyclovir could result in reactivation of the virus being treated. Furthermore, accidentally taking a dose of torsemide could lead to excessive urination and, potentially, other more serious adverse effects, including atrial fibrillation, chest pain, diarrhea, and others.
Who do you contact if your medication is affected?
If you have concerns or are experiencing problems with your medication, ensure you speak to your physician or a healthcare professional immediately.
Consumers with queries about the recall have been advised to call Apace Packaging on 270-434-2722 (Mon-Fri 8am-4pm CST).
Distributors with recalled products to return should contact customer service at AvKARE at 931-292-6222.
FDA’s MedWatch Adverse Event Reporting program
- Online at www.fda.gov/medwatch/report.htm
- By mail or fax (download the forms at www.fda.gov/MedWatch/getforms.htm)
- Call 1-800-332-1088 to request a reporting form.
