Wells Pharmacy Network is recalling all sterile human and veterinary products prepared between Feb. 22, 2016, and Sept. 14, 2016, that remain within the expiration date over concerns raised by the Food and Drug Administration (FDA) over sterility assurance. A list of affected products and lot numbers can be found on the company’s press release.
Administration of a drug product intended to be sterile that has microbial contamination may result in infections, some of which may be serious and life-threatening, the Food and Drug Administration (FDA) warned.
The long list of recalled products were used in a variety of indications and included testosterone injections, injections of the decongestant phenylephrine, and Vitamin D injections. No vial or portion of any lot of these medications has been found to be non-sterile, though there is a risk that some may be.
All recalled products have a label that includes the name Wells Pharmacy Network, logo, drug name, and expiration date. If unsure, customers can call the pharmacy to see if their product is on the list. To date, no adverse reactions have been reported related to this recall.
Anyone with affected products should discontinue use and quarantine any unused product until further instructions from the company. Providers who have dispensed any sterile products prepared by the company from Feb. 22 2016 to Sept. 14, 2016 should notify patients of the recall.
Any adverse events related to products involved in this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.