The company is voluntarily recalling one lot of its herpes virus medication over concerns about particulate matters inside the vial.
The recall was issued following a complaint of “dark red, brown and black” particulates in the vial, according to the announcement on the US Food and Drug Administration (FDA) website.
The product affected by the recall, AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), contains acyclovir, which the company noted to be “active against herpes virus.” It is used for treating “initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients and initial clinical episodes of herpes genitalis in immuno-competent patients.”
As the company, Eugia US, explained in the risk statement, having particulates in an intravenous product may lead to various issues, such as an allergic reaction, inflammation, or complications in the circulatory system, “which can be life-threatening.”
A previous paper on particulate matter in drug products also noted the various possible impacts of receiving an injection with particulate matter contamination, noting that the impacts would also depend on a number of factors such as the particle shape and size, the number of particles, the particles’ composition and even the route of administration.
In the case of recall, no specifics were given about the particulates’ characteristics but the company noted that ”
The recall affects products with lot number AC22006 that were packed in glass vials with the label NDC 55150-154-10. They have an expiration date of “08/2023” and the “entire lot” was shipped nationwide from June 8 to 13 earlier this year.
A photo of the recalled product’s label is available on the FDA website. The recall is being issued “to the consumer level.”
The company is already contacting its consignees via recall letters, while customers who may be in possession of them are being advised to either contact their physician or 1-888-280-2046.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” the company noted.