Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialis...
FDA Recall #D-0442-2019 — Class II — December 17, 2018
Product Description
Methylcobalamin lyophilized 50,000 mcg Injection, 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
252 vials
Distribution
Nationwide in the USA.
Code Information
Lots: 08212018@11 BUD: 12/19/2018; 10012018@1 BUD: 1/29/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated