FDAClass IIINovember 2, 2016

Invokamet recall: Labeling Error

Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC…

Why was Invokamet recalled?

Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.

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 #: 16GG581X, Exp 09/17

Product
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC…
Recalling firm
Janssen Ortho L.L.C.
Quantity
5346 bottles
Distribution
Nationwide and Puerto Rico
Recall date
November 2, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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