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.
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 1/5 (Low).
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
- 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
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