Warner Chilcott Recalls Jevantique Tablets Due to Chemical Contamination
Warner Chilcott is recalling Jevantique tablets because 2-phenylphenol was found in the product. The contamination resulted from migration from the cardboard cartons used for packaging.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a chemical contamination from packaging, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Warner Chilcott Company LLC is recalling Jevantique (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottles. The recall involves 17,136 bottles distributed nationwide in the US and in Puerto Rico. The affected lots are # 507694A (exp 02/13) and # 510041C (exp 05/13).
The recall was initiated after the firm's inspection discovered the presence of 2-phenylphenol in the product. This chemical contamination occurred due to migration from the cardboard cartons in which the product is packaged.
Consumers should check their medication for the specific lot numbers and expiration dates listed above. If they have the affected product, they should contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
- Manufacturer
- Warner Chilcott Company LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 17,136
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 # 507694A
- exp 02/13 Lot # 510041C
- exp 05/13
Distribution
Part of a larger recall action
This product is one of 3 recalled by Warner Chilcott Company LLC 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.
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