The Recall Desk
LowFDA (Drugs)·D-305-2013·Announced 2013-05-08

Warner Chilcott Recalls Femhrt Tablets Due to Chemical Contamination

Warner Chilcott is recalling 6,408 bottles of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates the product is unlikely to cause adverse health consequences. The hazard is a chemical contamination from packaging migration without reported injuries.

Plain-English summary

Warner Chilcott Company LLC is recalling 6,408 bottles of Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count. The affected product is identified by Lot# 507694B and has an expiration date of 02/13. The medication is prescription-only and was distributed nationwide in the United States and in Puerto Rico.

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 who have this specific lot of Femhrt should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.

The recalled product

Product
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Manufacturer
Warner Chilcott Company LLC
Category
Drug — Prescription Medication
Hazard
Affected units
6,408

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# 507694B
  • exp 02/13

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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