Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 ...
FDA Recall #D-0445-2019 — Class II — December 17, 2018
Product Description
Glutathione Injection, 200 mg/mL, 10 mL, 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
288 10 ml vials
Distribution
Nationwide in the USA.
Code Information
Lots: 09172018@7 BUD: 12/16/2018; 10292018@2 BUD: 1/27/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated