C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmac...
FDA Recall #D-1076-2020 — Class II — March 13, 2020
Product Description
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recalling Firm
Medical Center Pharmacy, Inc. — Cleveland, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2 bags
Distribution
Specific prescriptions to patients in TN
Code Information
Lot: 03022020@3 BUD: 03/16/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated