The Recall Desk

FDA (Drugs) recall action 81289

Janssen Pharmaceuticals, Inc. recalled 2 products on 2018-11-14

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-11-14
Critical
0
Units
1,777

Why these products were recalled

Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2018-11-14

    Janssen Recalls Ortho-Novum 7/7/7 Tablets Due to Incorrect Dispenser Instructions

    Janssen Pharmaceuticals is recalling Ortho-Novum 7/7/7 tablets because the packaging included instructions for the wrong type of pill dispenser.

    Product
    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); and b) 12 Veridate Tablet Disp
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-11-14

    Janssen Recalls Ortho-Novum 1/35 Due to Incorrect Dispenser Instructions

    Janssen Pharmaceuticals is recalling Ortho-Novum 1/35 tablets because the packaging included instructions for the wrong type of pill dispenser.

    Product
    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 by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured
    Category
    Distribution
    0 states