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
Reported: November 2, 2016 Initiated: October 19, 2016 #D-0115-2017
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.
Details
- Recalling Firm
- Janssen Ortho L.L.C.
- Units Affected
- 5346 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Gurabo, PR
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Janssen Ortho L.L.C.. Units affected: 5346 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 2, 2016. Severity: Low. Recall number: D-0115-2017.
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