Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 U...
FDA Recall #D-0440-2019 — Class II — December 17, 2018
Product Description
Vitamin D3 50,000iu/mL, injection 5 mL, 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
210 5 ml vials
Distribution
Nationwide in the USA.
Code Information
Lots: 09112018@10 BUD: 1/2/2019; 09212018@9 BUD: 1/12/2019; 11132018@10 BUD: 2/27/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated