Medications & Supplements/Prescription Drugs

Coast Quality Pharmacy LLC: Macroaggregated Albumin (MAA) Kits Recalled for Lack of Sterility Assurance

Agency Publication Date: May 10, 2018

Summary

Coast Quality Pharmacy LLC is recalling 52 units of Macroaggregated albumin (MAA) kits, also known as Aggregated and non-Aggregated Human Serum Albumin. These kits are used to prepare injectable Tc99m MAA medications. The recall was initiated because the company cannot guarantee that the products are sterile, which could lead to serious infections when the medication is administered. The affected vials were distributed in Alabama, California, Florida, Michigan, South Carolina, and Texas.

Risk

A lack of sterility assurance means the injectable medication could contain bacteria or other contaminants. Injecting a non-sterile product into the bloodstream can lead to life-threatening infections or other severe medical complications.

What You Should Do

Check your medication vial labels for the product name 'Macroaggregated albumin (MAA) kit' or 'Aggregated and non-Aggregated Human Serum Albumin.'
Verify if your product belongs to affected Lot MAA-171219BM with a Beyond Use Date (BUD) of 4/19/18, or Lot MAA-180226BM with a Beyond Use Date (BUD) of 06/26/18.
Immediately stop using any products from these specific lots and secure them to prevent accidental administration.
Contact your healthcare provider or pharmacist immediately if you have received an injection from one of these lots and are experiencing unusual symptoms.
Return any unused vials to the pharmacy where you received them for a refund and contact Coast Quality Pharmacy LLC for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Macroaggregated albumin (MAA) kit (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

Lot Numbers:

MAA-171219BM (BUD: 4/19/18)

MAA-180226BM (BUD: 06/26/18)

Date Ranges: 4/19/18, 06/26/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80005

Status: Resolved

Manufacturer: Coast Quality Pharmacy LLC

Sold By: AnazaoHealth

Manufactured In: United States

Units Affected: 52 vials

Distributed To: Alabama, California, Florida, Michigan, South Carolina, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication vial labels for the product name 'Macroaggregated albumin (MAA) kit' or 'Aggregated and non-Aggregated Human Serum Albumin.'

Verify if your product belongs to affected Lot MAA-171219BM with a Beyond Use Date (BUD) of 4/19/18, or Lot MAA-180226BM with a Beyond Use Date (BUD) of 06/26/18.

Immediately stop using any products from these specific lots and secure them to prevent accidental administration.

Contact your healthcare provider or pharmacist immediately if you have received an injection from one of these lots and are experiencing unusual symptoms.

Return any unused vials to the pharmacy where you received them for a refund and contact Coast Quality Pharmacy LLC for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.