Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit ...

FDA Recall #D-0470-2019 — Class II — December 17, 2018

Recall #D-0470-2019 Date: December 17, 2018 Classification: Class II Status: Terminated

Product Description

Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 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

5 vials

Distribution

Nationwide in the USA.

Code Information

Lot: 11072018@2 BUD: 12/14/2018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated