Reported Nov 14, 2018 · Terminated
Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28),…
Janssen Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Janssen Pharmaceuticals, Inc. · 1125 Trenton-Harbourton Rd. · Titusville, NJ · 08560
Is this the product you have?
- Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only
- Manufactured byJanssen Ortho, LLC, Manati, Puerto Rico 00674
- Manufactured forJanssen Pharmaceuticals, Inc., Titusville, New Jersey 08560
- Lot codes and dates
Lot # 18BM114Exp. 03/2020
- Amount recalled
- 1,777 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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