FDAClass IISeptember 5, 2012

Multihance Multipack recall: Sterility Concern

Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a)…

Why was Multihance Multipack recalled?

Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

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 #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12

Product
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a)…
Recalling firm
Bracco Diagnostics Inc
Quantity
4,870 Vials
Distribution
Nationwide
Recall date
September 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls