FDA Drug recall D-0801-2018
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Ace…
- FDA Drug
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Ace… by Coast Quality Pharmacy, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0801-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-26 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Coast Quality Pharmacy |
| Distribution | AL, CA, FL, MI, SC, TX |
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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Coast Quality Pharmacy recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0801-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.