FDAClass IIIFebruary 19, 2014

VoLumen Barium Sulfate Suspension recall

VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake…

Why was VoLumen Barium Sulfate Suspension recalled?

Failed Stability Testing: This product is below specification for preservative content.

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 #: 67603, Expiry: 2/2014

Product
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake…
Recalling firm
Bracco Diagnostics Inc
Quantity
54,648 bottles
Distribution
Nationwide including Puerto Rico
Recall date
February 19, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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