Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy ...
FDA Recall #D-0447-2019 — Class II — December 17, 2018
Product Description
Thymosin Beta-4, 15 mg 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
94 vials
Distribution
Nationwide in the USA.
Code Information
Lots: 08302018@8 BUD: 2/26/2019; 10012018@2 BUD: 3/30/2019; 07052018@2 BUD: 01/01/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated