Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists...
FDA Recall #D-0475-2019 — Class II — December 17, 2018
Product Description
Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, 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
8 10ml vials
Distribution
Nationwide in the USA.
Code Information
Lot: 10302018@3 BUD: 12/14/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated