FDAClass IIMay 16, 2018

Macroaggregated albumin recall: Sterility Concern

Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol…

Why was Macroaggregated albumin recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18

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…
Recalling firm
Coast Quality Pharmacy LLC
Quantity
52 vials
Distribution
AL, CA, FL, MI, SC, TX
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls