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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (incorrect instructions) which is a minor labeling error that might cause temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria.
Plain-English summary
Janssen Pharmaceuticals, Inc. is recalling 1,777 cartons of Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen. The product is distributed nationwide in the USA and is identified by Lot # 18BM114 with an expiration date of 03/2020.
The recall was initiated due to a labeling error. The instructions included for use with the Veridate dispenser incorrectly contained instructions for the Dialpak dispenser. This is a Class II recall, indicating that use of or exposure to the product might cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on how to proceed. The product is prescription-only and was manufactured by Janssen Ortho, LLC in Manati, Puerto Rico, for Janssen Pharmaceuticals, Inc. in Titusville, New Jersey.
The recalled product
- 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…
- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 1,777
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 18BM114
- Exp. 03/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Janssen Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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