The makers of ORTHO-NOVUM® have issued a voluntary recall of three lots of the brith-control pill due to the patient information provided inside the packages does not include the instructions for the Veridate dispenser. The products the company is recalling are ORTHO-NOVUM® 1/35 (norethindrone/ethinyl estradiol) Tablets, and ORTHO-NOVUM® 7/7/7 (norethindrone/ethinyl estradiol) Tablets.
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.
The company and the FDA state that the product is still safe and effective for use as long as the proper dispenser instructions are used. Those who have been prescribed either pill should continue taking 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).
The products were distributed nationwide to wholesalers, distributors, and pharmacies. They have been notified of the recall through a recall letter instructing them to return the affected products.
In case you take either of these products, please check and verify the number on the pouch, and verify with your doctor that you are taking them accurately.
The lots being recalled are:
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