VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Pre...
FDA Recall #D-0759-2017 — Class II — April 18, 2017
Product Description
VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy
Reason for Recall
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recalling Firm
Key Pharmacy and Compounding Center — Federal Way, WA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
10 mL
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # 02-23-2017@35, Exp 4/24/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated