D-0801-2018 Class II Terminated
FDA drug recall D-0801-2018 was initiated by Coast Quality Pharmacy LLC on April 26, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 4, 2020). Affected quantity: 52 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 16, 2018
- Initiation Date
- April 26, 2018
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 vials
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
AL, CA, FL, MI, SC, TX
Code Information
Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18