D-1077-2020 Class II Terminated

Recalled by Medical Center Pharmacy, Inc. — Cleveland, TN

Recall Details

Product Type
Drugs
Report Date
April 8, 2020
Initiation Date
March 13, 2020
Termination Date
October 14, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 bottles

Product Description

*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.

Reason for Recall

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Distribution Pattern

Specific prescriptions to patients in TN

Code Information

Lot: 03022020@5 BUD: 03/16/2020