Massive recall on Wells Pharmacy human and veterinarian products

Ocala, Florida – Wells Pharmacy Network (WPN) has recalled all sterile human and veterinary products prepared between February 22, 2016, and September 14, 2016.

Also on the list (below), are products that remain within expiry, but are being recalled due to the Food and Drug Administration’s (FDA) concern over the lack of sterility assurance.

A spokesperson from the FDA said, “Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.”

All recalled products have a label that includes the name Wells Pharmacy Network, logo, drug name, and expiration date. If unsure, consumers 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 that have received any sterile compounded products prepared between the aforementioned dates, 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.

Consumers with questions regarding this recall should 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.

If you are a consumer and have experienced any problems; contact your  physician, healthcare provider, or veterinarian immediately.

Providers who have dispensed any sterile products prepared between the aforementioned dates 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, or call 1-800-332-1088.
• 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 in cooperation with the FDA.

List of recalled products: (You can also download the list here.)

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