Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Well Care Compounding Pharmacy Issues Voluntary Statewide Recall of All Sterile Compounded Products Due to Lack Of Assurance if Sterility Concerns

For Immediate Release

May 17, 2016

Contact

Consumers

Well Care Compounding Pharmacy
info@mywellcarepharmacy.com
(702) 553-2575

Announcement

Well Care Compounding Pharmacy, Las Vegas, Nevada is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to the Food and Drug Administration’s (FDA) concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016.

Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.

All recalled products have a label that includes the name Well Care Compounding Pharmacy, logo, drug name, and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date.

We have not received any reports of adverse effects or injuries to date. We are conducting this recall after an inspection conducted by the FDA. Customers that have any recalled products should immediately stop using it and contact the pharmacy to arrange for the return of any unused product.

Well Care Compounding Pharmacy takes the utmost care to ensure patient safety and performing this voluntary recall. Customers with questions regarding this recall can call the pharmacy by phone (702) 553-2575 Monday through Friday 9am – 6pm PST or email at info@mywellcarepharmacy.com.

Adverse reactions or quality problems experiences with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  1. Complete and submit the report online: www.fda.gov/medwatch/report.htm
  2. 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

Well Care Compounding Pharmacy regrets any inconvenience and disruption due to this recall on its customers, however, the safety of customers are the primary concern.

This recall is being conducted with the knowledge of the Food and Drug Administration.

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Page Last Updated: 05/17/2016
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