Macroaggregated albumin kit recalled over sterility concerns

Recall date

April 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Coast Quality Pharmacy LLC recalls Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin…

Recall number

D-0801-2018

FDA classification

Class II

Brand / firm

Coast Quality Pharmacy LLC

Sold / distributed

AL, CA, FL, MI, SC, TX

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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