man weighing himself on medical scale

Sterile Recall FAQs

In the coming days you will receive a letter from us with all the information you need. It will come from Wells Pharmacy Network and will be marked IMPORTANT. It will contain your specific medication and instructions on how to dispose or return the medication.

Email WPNConcerns@wellsrx.com

There is nothing you need to do.

Our facilities are undergoing an expansion and enhancement and the FDA would have preferred that we stop production during construction. They have asked that we recall medications made during that time period even though no adverse events or sterility issues have been reported.  Out of an abundance of caution we are complying with the FDA’s request.

The key thing to note is that this is a Voluntary recall and that no vial or portion of any lot of these medications has been found to be non-sterile. This voluntary recall was based on the FDA’s concern only. Wells Pharmacy is still open and we are adhering to the FDA’s request.

No, the recall is focused on sterile injectable medications prepared between February 22, 2016 and September 14, 2016, that has not yet expired. Non-sterile compounds like creams, gels, capsules and tablets, as well as sterile implantable pellets are not included.

  • Every lot indicated in the recall passed sterility testing and we can provide a copy of that report to your physician
  • There have been no adverse events reported for any of the medications

Dowload the complete list here.

We are happy to send a copy of the sterility report to your physician on your behalf. Please send an email to WPNQuality@wellsrx.com with the subject line Sterility Report and provide your name, the medication and lot numbers listed in your recall letter,  as well as the name of your physician and we will email your physician the report(s).

The FDA has instructed us to inform you to:

  • Discontinue use of the products
  • Put aside any unused product until you receive our letter with instructions on how to return any unused medication
 
When you receive your letter and validate that your medication is on the list, you will be instructed to email or to return recalled medication for both prescribers and patients, please send the following information to:

 

WPNquality@Wellsrx.com

Please include the following:

  1. Patient name as listed on your prescription
  2. Drug name not used
  3. Address drug is located
  4. Doctors name who prescribe your medication
  5. Best phone # and email we can reach out to you with questions in needed.
 
According to the FDA.gov website:

Drug Disposal Guidelines and Locations

The following guidelines were developed to encourage the proper disposal of medicines and help reduce harm from accidental exposure or intentional misuse after they are no longer needed:

  • Follow any specific disposal instructions on the prescription drug labeling or patient information that accompanies the medicine. Do not flush medicines down the sink or toilet unless this information specifically instructs you to do so.
  • Take advantage of programs that allow the public to take unused drugs to a central location for proper disposal. Call your local law enforcement agencies to see if they sponsor medicine take-back programs in your community. Contact your city’s or county government’s household trash and recycling service to learn about medication disposal options and guidelines for your area.
  • Transfer unused medicines to collectors registered with the Drug Enforcement Administration (DEA). Authorized sites may be retail, hospital or clinic pharmacies, and law enforcement locations. Some offer mail-back programs or collection receptacles (“drop-boxes”). Visit the DEA’s website or call 1-800-882-9539 for more information and to find an authorized collector in your community.

If no disposal instructions are given on the prescription drug labeling and no take-back program is available in your area, throw the drugs in the household trash following these steps:

  1. Remove them from their original containers and mix them with an undesirable substance, such as used coffee grounds, dirt or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs).
  2. Place the mixture in a sealable bag, empty can or other container to prevent the drug from leaking or breaking out of a garbage bag.

FDA’s Ilisa Bernstein, Pharm.D., J.D., offers a few more tips:

  • Scratch out all identifying information on the prescription label to make it unreadable. This will help protect your identity and the privacy of your personal health information.
  • Do not give your medicine to friends. Doctors prescribe medicines based on your specific symptoms and medical history. Something that works for you could be dangerous for someone else.
  • When in doubt about proper disposal, ask your pharmacist.

A replacement will be processed for any unused portion of your medication. If you paid for your medication directly to Wells Pharmacy we will send you either a replacement from one of the partner pharmacies that is helping us (see below) or you can wait until our facilities are back up and running once our construction is completed in a few weeks. If your physician paid for your medication we will work with he or she directly to process your replacement.

Wells is working closely with FDA Registered 503B Outsourcing facilities to supply us with the sterile injectable medications that you need. We can refill your prescription from this new supply of medications or if you’d prefer we can transfer your prescription.

The medication you receive through this process will come in a Wells Pharmacy Network box but, but you’ll see an additional auxiliary label from a pharmacy other than Well Pharmacy Network. *Follow instructions on the Wells Pharmacy label..

Our customer service team is ready to assist you, please contact them at 800-622-4510

We are required under federal law to disclose the information to all patients that have received the medication, whether it is administered or not. The FDA feels that this is the best method of due diligence to recover all remaining recalled medications in the market. Wells Pharmacy Network wants to make clear that


NO MEDICATION on this list or any sterile compounded product to date with Wells Pharmacy Network has been reported to be nonsterile. We have laboratory results indicating the medication sterility to provide to all patients that received this product at your request. We value your partnership and understand your frustration with this recall. Wells Pharmacy Network is willing to assist in any way possible to help your patients better understand this process and the safety and quality of the services both our businesses provide.

 
In FDA recall situations, each individual State Board of Pharmacy will also notify patients of the recall. Again, this is out of an abundance of caution and to notify the public. Any affected patient will be receiving a personalized mailed letter from Wells Pharmacy.
 
Our recall is considered a patient level recall, meaning we are required to notify patients. However, we are working to also notify all the prescribers via email with a list of their patients affected by the recall. Our goal is to have this out to the physicians during the week of September 26, 2016. If your physician has questions, please direct him or her to contact us at 800-794-2360 or WPNQuality@wellsrx.com
 

We are here to help. We have set up an email address and phone line for all related questions:

Quality Hotline: 800-794-2360

Email: WPNQuality@wellsrx.com