FDAClass IISeptember 20, 2017

Mannitol 20% recall: Sterility Concern

Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

Why was Mannitol 20% 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 #: 070717ML, Exp. 1/7/18

Product
Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Recalling firm
Bella Pharmaceuticals, Inc.
Quantity
10 vials
Distribution
Nationwide within USA
Recall date
September 20, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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