# FDA recall D-1063-2015

> **Janssen Pharmaceuticals, Inc.** · Class II · drug recall initiated 2015-04-29.

## Product

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.

## Reason for recall

Subpotent Drug

## Distribution

Nationwide and Canada

## Key facts

- **Recall number:** D-1063-2015
- **Recalling firm:** Janssen Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-29
- **Report date:** 2015-05-20
- **Termination date:** 2018-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Titusville, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1063-2015

## Citation

> AI Analytics. FDA recall D-1063-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1063-2015. Source: US FDA. Licensed CC0.

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