Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 3181...
FDA Recall #D-0469-2019 — Class II — December 17, 2018
Product Description
Niacinamide injection, 100mg/mL, 5mL 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
1 vial
Distribution
Nationwide in the USA.
Code Information
Lot: 11022018@9 BUD: 12/17/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated