Reported Nov 2, 2016 · Terminated
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product…
Janssen Ortho LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Janssen Ortho L.L.C. · Carr # 933 Km 0.1 · Gurabo, PR · 00778
Is this the product you have?
- Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only
- Finished product manufactured byJanssen Ortho, LLC, Gurabo PR 00778
- Manufactured forJanssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60
- Lot codes and dates
Lot #: 16GG581XExp 09/17
- Amount recalled
- 5346 bottles
Where it was sold
- Nationwide
- PR
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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