Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance

Ocala, Florida – 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 (list below) due to the Food and Drug Administration’s (“FDA”) concern over a lack of sterility assurance.

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.

WPN takes the utmost care to ensure patient safety. All patients and providers that 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 EST 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 EST or email at WPNQuality@wellsrx.com. Customers should contact their physician, healthcare provider, or veterinarian if they have experienced any problems that may be related to using these products. 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 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:

• For adverse events in Humans please use FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• For reporting animal adverse drug events, please follow the link to the FORM FDA 1932a found at: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

This recall is being conducted with the knowledge of and in cooperation with the FDA.

Again, WPN’s primary concern is your safety and WPN is taking this action out of an abundance of caution. Thank you for your support.

List of products to be recalled:

###