Reported Nov 14, 2018 · Terminated

Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day…

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

3 of 3 products

Products covered by this recall
#	Product as published
1	Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06)
2	and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674
3	Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.

Lot codes and dates: Lot #: a) 18CM120
Exp 03/2020
b) 18BM110
Exp. 03/2020
Amount recalled: a) 3,956 cartons; b) 1 carton

The agency filed one notice per product. You are reading one of them; the other one is below.

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.

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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