Recalls / Class III
Class IIID-0115-2017
Product
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
- Brand name
- Invokamet
- Generic name
- Canagliflozin And Metformin Hydrochloride
- Active ingredients
- Canagliflozin, Metformin Hydrochloride
- Route
- Oral
- NDCs
- 50458-540, 50458-541, 50458-542, 50458-543, 50458-940, 50458-941, 50458-942, 50458-943
- FDA application
- NDA204353
- Affected lot / code info
- Lot #: 16GG581X, Exp 09/17
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.
Recalling firm
- Firm
- Janssen Ortho L.L.C.
- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Type
- Voluntary: Firm initiated
- Address
- Carr # 933 Km 0.1, Gurabo, Puerto Rico 00778
Distribution
- Quantity
- 5346 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-10-19
- FDA classified
- 2016-10-25
- Posted by FDA
- 2016-11-02
- Terminated
- 2018-05-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0115-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.