Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31...
FDA Recall #D-0454-2019 — Class II — December 17, 2018
Product Description
Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Promise Pharmacy, LLC — Palm Harbor, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
139 vials
Distribution
Nationwide in the USA.
Code Information
09212018@12 BUD: 12/20/2018; 11062018@3 BUD: 6/4/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated