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| The United States: 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 (English Only) |
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The US Food and Drug Administration (FDA) announces that 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 three lots affected by this recall are:
- ORTHO-NOVUM® 1/35 (Lot No.: 18BM114; Expiration Date: 03/2020)
- ORTHO-NOVUM® 7/7/7 (Lot No.: 18CM120; Expiration Date: 03/2020)
- ORTHO-NOVUM® 7/7/7 (Lot No.: 18BM110; Expiration Date: 03/2020)
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm625012.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Monday, Nov 5, 2018
Issued at HKT 15:00
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