# FDA recall D-0115-2017

> **Janssen Ortho L.L.C.** · Class III · drug recall initiated 2016-10-19.

## 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

## 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0115-2017
- **Recalling firm:** Janssen Ortho L.L.C.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-10-19
- **Report date:** 2016-11-02
- **Termination date:** 2018-05-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gurabo, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0115-2017

## Citation

> AI Analytics. FDA recall D-0115-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0115-2017. Source: US FDA. Licensed CC0.

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