November 28, 2019
Re: Estriol USP Drug Recall
It recently came to our attention that one of our suppliers was not following FDA protocol for inspections. Concerned for the health of our patients, MEDISCA began working with the FDA to conduct extra testing to ensure that the imported materials from this supplier met or exceeded specification requirements. Tests revealed that two lots of materials from this vendor fell outside specs, but while working with the FDA, we decided that we would recall every lot of materials obtained from this vendor. We immediately sent a formal recall letter to begin the process of notifying and caring for our effected clients.
To date, there are no known adverse reactions to these medications and we are working to follow all recall protocol because here at MEDISCA we believe that patient safety and FDA compliance is what sets us apart as an industry leader. We value our integrity and commitment to high quality products and want our clients to know that if we ever find a discrepancy, we will make it right. We strive to make sure that all our compounding materials are 100% FDA compliant and put your patients’ safety as our highest priority.
If you have any questions regarding the recall or our policy on testing or standards, please don’t hesitate to contact us.
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