Drug product
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
D-0801-2018
Product summary
- Event
- Event 80005
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52 vials
- Official record key
drug-enforcement:D-0801-2018
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18
Distribution pattern: AL, CA, FL, MI, SC, TX
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility