The Recall Desk
LowFDA (Drugs)·D-142-2013·Announced 2013-02-06

Femtrace 0.45 mg Tablets Recalled for Moisture Ingress

Warner Chilcott is recalling 3,155 bottles of Femtrace 0.45 mg tablets due to moisture ingress that failed impurity specifications.

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 agency classification is FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a packaging integrity issue (moisture ingress) without reported injuries or illnesses.

Plain-English summary

Warner Chilcott Company LLC is recalling 3,155 bottles of Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets. The product was manufactured by Pharmaceutics International Inc in Hunt Valley, MD, for Warner Chilcott Company LLC in Fajardo, PR. The recall is due to failed impurity/degradation specifications caused by moisture ingress in individual bottles.

The affected product is identified by the code 0.45 mg: 505969A. The recall is distributed US Nationwide. No specific lot numbers or dates are provided in the source text.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The source text does not specify a return address or specific consumer action beyond the standard recall protocol.

The recalled product

Product
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Manufacturer
Warner Chilcott Company LLC
Category
Drug — Prescription Medication
Hazard
Affected units
3,155

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 (1)

  • 0.45 mg: 505969A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Warner Chilcott Company LLC

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Same hazard · moisture ingress

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