Macroaggregated albumin — Class II drug recall D-0801-2018
Terminated recall by Coast Quality Pharmacy LLC, reported 2018-05-16, distributed in AL, CA, FL, MI, SC, TX. Lack of Assurance of Sterility
| Recall number | D-0801-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coast Quality Pharmacy LLC, Tampa, FL, United States |
| Recall initiated | 2018-04-26 |
| Classified | 2018-05-10 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-06-04 |
| Distributed | AL, CA, FL, MI, SC, TX |
| Quantity | 52 vials |
| Reason classes | sterility |
| Lot numbers | MAA-171219BM, MAA-180226BM |
| Expiration dates | 2018-04-19, 2018-06-26 |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0801-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.