Janssen Recalls Subpotent Ortho-Cept Oral Contraceptive Tablets
Janssen Pharmaceuticals is recalling Ortho-Cept tablets because they contain less active ingredient than labeled. The recall covers 16,861 cartons distributed in the US and Canada.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric, as it involves a potential risk of harm (reduced contraceptive efficacy) without reported fatalities.
Plain-English summary
Janssen Pharmaceuticals, Inc. is voluntarily recalling 16,861 cartons of Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets. The recall was initiated on April 29, 2015, and was classified as Class II by the FDA. The affected product is a prescription-only oral contraceptive available in 28-count blister packs.
The reason for the recall is that the tablets are subpotent, meaning they contain less of the active drug ingredient than stated on the label. This defect may result in reduced effectiveness of the contraceptive. The affected lots are Lot # 13CM724 (US) and Lot # (L) 13DM732 (Canada), both with an expiration date of 09/15.
The product was distributed nationwide in the United States and in Canada. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance. The recall was terminated on July 13, 2018.
The recalled product
- Product
- Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands…
- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Category
- Drug — Oral Contraceptive
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 (3)
- Lot # 13CM724
- Exp.09/15 (US) Lot # (L) 13DM732
- Exp. 09/15 (Canada)
Distribution
Distributed nationwide across the United States.
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