Coast Quality Pharmacy MAA Kit Recall: Lack of Sterility Assurance
Coast Quality Pharmacy LLC recalls MAA kits for Tc99m MAA preparation due to lack of sterility assurance. This affects specific lots manufactured between April 2018 and June 2: 2018. No remedy is specified in the recall notice.
Recall notice
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Coast Quality Pharmacy LLC is recalling MAA kits used for preparing Tc99m MAA due to a lack of sterility assurance. This means the products could be contaminated, posing a risk of infection if used in medical procedures. Read more at govinfonow.com/recall/40587-coast-quality-pharmacy-maa-kit-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/40587-coast-quality-pharmacy-maa-kit-recall-lack-of-sterility-assurance · Updated October 7, 2026 · FDA enforcement record: FDA #D-0801-2018
Cite this page
“Coast Quality Pharmacy MAA Kit Recall: Lack of Sterility Assurance.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40587-coast-quality-pharmacy-maa-kit-recall-lack-of-sterility-assurance. Based on FDA recall #D-0801-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0801-2018%22&limit=1).
Why it’s dangerous
The kits lack sterility assurance, meaning they could be contaminated with harmful microorganisms. If used in medical procedures, this contamination could lead to infections in patients.
Who’s affected
Healthcare professionals who use these kits for medical imaging procedures are most at risk. Patients receiving these procedures may be affected if the kits are used without proper sterility.
How to tell if you have this one
Check for the product names: Macroaggregated albumin (MAA) kit, Aggregated and non-Aggregated Human Serum Albumin. Look for lot numbers MAA-171219BM or MAA-180226BM, manufactured with bud dates 4/19/18 or 06/26/18.
- Brand
Coast Quality Pharmacy LLC- Category
Drug
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the product label to determine if it is affected.
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “AL, CA, FL, MI, SC, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Florida, Michigan, South Carolina, Texas.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0801-2018 (April 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0801-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.