Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US...
FDA Recall #D-0474-2019 — Class II — December 17, 2018
Product Description
Procaine HCl, 2% 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
11 10ml vials
Distribution
Nationwide in the USA.
Code Information
Lots: 11082018@4 BUD: 12/23/2018; 10302018@4 BUD: 12/14/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated