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Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, ...

FDA Recall #D-0115-2017 — Class III — October 19, 2016

Recall #D-0115-2017 Date: October 19, 2016 Classification: Class III Status: Terminated

Product Description

Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60

Reason for Recall

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.

Recalling Firm

Janssen Ortho L.L.C. — Gurabo, PR

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

5346 bottles

Distribution

Nationwide and Puerto Rico

Code Information

Lot #: 16GG581X, Exp 09/17

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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