Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compound...
FDA Recall #D-0446-2019 — Class II — December 17, 2018
Product Description
Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 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
196 50 ml vials
Distribution
Nationwide in the USA.
Code Information
Lots: 10152018@1 BUD: 1/13/2019; 10312018@2 BUD: 1/29/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated