Why it was recalled
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Product description
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
Lot numbers, UPCs & expiration codes
0.45 mg: 505969A
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-142-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 21, 2012
- FDA report date
- Feb 6, 2013
- Quantity
- 3155 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Warner Chilcott Company LLC
Original FDA data
Every field from FDA enforcement report D-142-2013, exactly as published.
Show all FDA fields
- City
- Fajardo
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 64014
- Address
- Road 195, Km 1.1
- Address (line 2)
- Union Street
- Code information
- 0.45 mg: 505969A
- Postal code
- 00738
- Report date
- Feb 6, 2013
- Product type
- Drugs
- Recall number
- D-142-2013
- Classification
- Class III
- Recalling firm
- Warner Chilcott Company LLC
- Product quantity
- 3155 bottles
- Termination date
- Jun 16, 2015
- Reason for recall
- Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide
- Recall initiation date
- Dec 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Jan 31, 2013