FDA MedWatch - Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance

Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance

AUDIENCE: Pharmacy, Veterinary Medicine

ISSUE: Well Care Compounding Pharmacy is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to FDA concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016. Well Care Compounding Pharmacy is conducting this recall after an FDA inspection. 

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

BACKGROUND: 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.

RECOMMENDATION: Customers that have any recalled products should immediately stop using it and contact the pharmacy to arrange for the return of any unused product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm501624.htm