Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25...
FDA Recall #D-0438-2019 — Class II — December 17, 2018
Product Description
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, 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
204 10 ml vials
Distribution
Nationwide in the USA.
Code Information
Lots: 10092018@4 BUD: 1/7/2019; 11122018@7 BUD: 2/10/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated