Drug product
C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.
D-1073-2020
Product summary
- Event
- Event 85217
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 bottles
- Official record key
drug-enforcement:D-1073-2020
Official wording
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Code information: Lot: 03042020@28 BUD: 03/18/2020; 03032020@3 BUD: 03/17/2020
Distribution pattern: Specific prescriptions to patients in TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility