D-1074-2020 Class II Terminated
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
- 1 bottle
Product Description
C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
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: 03042020@7 BUD: 03/18/2020