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(Last Updated On: November 15, 2018)

Public Alert No: 36/2018 – Recall Of Ortho-Novum 1/35 (One Lot) And Ortho-Novum 7/7/7 (Two Lots)

The National Agency for Food and Drug Administration and Control has been informed of the voluntary recall of ORTHO-NOVUM 1/35 (one lot) and ORTHO-NOVUM 7/7/7 (two lots) by Jansen pharmaceuticals. The product was recalled over incorrect dispenser instructions and packaging error. Consumers could take incorrect ‘inactive’ pill instead of an ’active pill’ if they follow the directions included in these lots, which could lead to breakthrough bleeding or an unintended pregnancy, according to the FDA.

The product is a birth control pill indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

However, the product itself remains safe and effective for use with the appropriate dispenser instructions.

Product information

Product names: ORTHO-NOVUM 1/35 (one lot) and ORTHO-NOVUM 7/7/7 (two lots)

Product name NDC number on carton NDC number on pouch Lot number Expiration date
Ortho-Novum 1/35 5045817606 5045817628 18BM114 March 2020
Ortho-Novum 7/7/7 5045817806 5045817828 18CM120 March 2020
Ortho-Novum 7/7/7 5045817812 5045817812 18BM110 March 2020

Product description: each pack contains 21 pills

Product manufacturers: Janssen pharmaceuticals, Titusville NJ USA.

NAFDAC implores all importers, wholesalers and retailers to immediately stop the importation, distribution and sale of the product.

Health care providers and members of the public are also advised to stop the administration and use of the affected products to avoid negative health implications. Healthcare providers and anyone in possession of the affected products should submit them to the nearest NAFDAC office.

Consumers are advised to report adverse events related to the use on any of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC………….Safeguarding the health of the Nation!!!

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