The Recall Desk
ModerateFDA (Drugs)·D-304-2013·Announced 2013-05-08

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.

What this means for you

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

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