Janssen Issues Recall for ORTHO-NOVUM 1/35, ORTHO-NOVUM 7/7/7

Janssen Pharmaceuticals 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.

ORTHO-NOVUM 1/35 and ORTHO-NOVUM 7/7/7 tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
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 (with hormones) (peach for ORTHO-NOVUM 1/35; white, light-peach and peach for ORTHO-NOVUM 7/7/7) for three weeks, followed by the one week of green "reminder" pills (without hormones).

This recall only affects the U.S., and no other ORTHO contraceptive products beyond the three lots listed above are impacted by this recall action. ORTHO TRI-CYCLEN LO, ORTHO TRI-CYCLEN, ORTHO MICRONOR and ORTHO CYCLEN are not affected.

Products were distributed in the U.S. to wholesalers, distributors and pharmacies, and they have been notified by recall letter to return affected products.
stop taking the product and if they do miss a dose, they should follow the instructions included in the packet.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Administration.

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