FDA Recall Alert: Wells Pharmacy Network Recalls All Sterile Products

Today, the Food and Drug Administration (FDA) announced Wells Pharmacy Network (“WPN”) is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016, and September 14, 2016, and that remain within expiry due to the FDA’s concern over a lack of sterility assurance.

Visit FDA’s website for a full list of drugs included in the recall. The list includes several ophthalmic drugs.

Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.

The recalled products were used for a variety of indications. No vial or portion of any lot of these medications has been found to be non-sterile. 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 determine if their product is on the list. To date, no adverse events have been reported.

All patients and providers who received any sterile compounded products prepared between February 22, 2016, and September 14, 2016, and that remain within expiry, should take the following actions:

  • Discontinue use of the products;
  • Quarantine any unused product until further instructions are received on how to return the product; and
  • Contact WPN at the Quality hotline at 800-794-2360 Monday through Friday, between 9:00 am and 6:00 pm ET or email at WPNQuality@wellsrx.com to discuss the return of any unused sterile product.

Customers with questions regarding this recall can contact WPN at the Quality hotline at 800-794-2360 Monday through Friday between 9:00 am and 6:00 pm ET or email at WPNQuality@wellsrx.com. Providers who have dispensed any sterile products prepared between February 22, 2016, and September 14, 2016, to a patient(s) for use outside of the provider’s office should contact the patient(s) to whom the product was dispensed and advise the patient(s) of this recall.

Adverse reactions or quality problems experienced with the use of these products in humans or animals may be reported to FDA in the following ways:

If you have additional questions, please contact Allison Madson, manager of regulatory affairs, at amadson@ascrs.org or 703-591-2220.