Veridate Dispenser Instructions
At Janssen, we believe our first responsibility is to the individuals who use our products and everything we do must be of high quality.
The patient information provided inside packages of one lot of ORTHO-NOVUM® 1/35 and two lots of ORTHO-NOVUM® 7/7/7 did not include the appropriate instructions for the Veridate® dispenser. Instead, these lots include visual instructions for the Dialpak® dispenser previously used. On October 23, 2018 we initiated a voluntary recall at the pharmacy level of affected lots.
The ORTHO-NOVUM® product itself remains safe and effective for use with the appropriate dispenser instructions. Women should continue to take the 21 “active” pills for three weeks, followed by the one week of “reminder” pills.
IMPACTED ORTHO-NOVUM® 1/35 AND 7/7/7 VERIDATE® DISPENSER
ORTHO-NOVUM® medication remains safe and effective for use with the correct Veridate® dispenser instructions. You should not stop taking your ORTHO-NOVUM® without first speaking to your prescribing physician and if you do miss a dose you should follow the instructions included in the packet.
The potential risk of taking ORTHO-NOVUM® without the appropriate instructions for correct use of the Veridate® dispenser pack is that the consumer could take the pills in the incorrect order (still receiving an effective dose) or could take an inactive “reminder” pill instead of an “active” pill which could lead to breakthrough bleeding or an unintended pregnancy.
If you have any concerns about your ORTHO-NOVUM® oral contraception, please contact your prescribing physician.
IF THE LOT NUMBER OF YOUR ORTHO-NOVUM® 1/35 AND 7/7/7 BLISTER PACK INDICATES IT IS FROM ANY OF THE FOLLOWING LOTS, IT MAY NOT INCLUDE THE APPROPRIATE VISUAL INSTRUCTIONS FOR THE VERIDATE® DISPENSER CURRENTLY USED.
| Product Description | NDC Number (carton) | NDC Number (pouch) | Lot No. | Expiration Date |
|---|---|---|---|---|
| ORTHO-NOVUM® 1/35 | 5045817606 | 50458-176-28 | 18BM114 | 03/2020 |
| ORTHO-NOVUM® 7/7/7 | 5045817806 | 50458-178-28 | 18CM120 | 03/2020 |
| ORTHO-NOVUM® 7/7/7 | 5045817812 | 50458-178-12 | 18BM110 | 03/2020 |
You can confirm if your ORTHO-NOVUM® is affected by looking for the lot number just below the expiration date in the upper left-hand corner of the blister pack.
To help answer any questions on the Veridate® dispenser pack, check out the following materials:
If you have any questions about ORTHO-NOVUM® or proper usage of the Veridate® pill dispenser, please contact your prescribing physician or health care provider. You can also contact Janssen Medical Information on call: 1-800 526-7736 (1-800-JANSSEN) Monday through Friday from 9:00 am to 8:00 pm ET.
SEE VERIDATE® DISPENSER PACK ANNOUNCEMENT RELEASE HERE.