FDAClass IIMay 23, 2018

Kit for the Preparation of Technetium TC-99M Mebrofenin recall

Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured…

Why was Kit for the Preparation of Technetium TC-99M Mebrofenin recalled?

Failed Stability Specifications

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?

Part Number MEM05 and MEB30 both with expiry date 12/2018

Product
Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured…
Recalling firm
Pharmalucence, Inc.
Quantity
157 units (5 count) and 464 units (30 count)
Distribution
US Nationwide
Recall date
May 23, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls