From the Food & Drug Administration
Status: Currently in Shortage
Date first posted: 09/22/2017
Therapeutic Categories: Neurology
10 mg/2 mL (5 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1273-32)
Next Delivery: November 2018; Estimated Recovery: March 2019
For details see FDA,
ORTHO-NOVUM 1/35 & ORTHO-NOVUM 7/7/7-Voluntary Recall
Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7
Due to Incorrect Veridate Dispenser Instructions
TITUSVILLE, NJ – Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM® 1/35 (norethindrone/ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM® 7/7/7 (norethindrone/ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM® does not include the appropriate instructions for the Veridate® dispenser.
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.
For full details see FDA,