D-1077-2020 Class II Terminated
FDA drug recall D-1077-2020 was initiated by Medical Center Pharmacy, Inc. on March 13, 2020 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. The recall status is terminated (terminated October 14, 2022). Affected quantity: 2 bottles.
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