Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy C...
FDA Recall #D-0476-2019 — Class II — December 17, 2018
Product Description
Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 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
15 10ml vials
Distribution
Nationwide in the USA.
Code Information
Lot: 10312018@3 BUD: 12/15/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated