Why it was recalled
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Product description
EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***
Lot numbers, UPCs & expiration codes
Lot Number: EHAD Exp. 07/14
Where it was sold
Products were distributed 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-146-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 19, 2012
- FDA report date
- Feb 13, 2013
- Quantity
- 4, 835 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Therapeutics Inc
Original FDA data
Every field from FDA enforcement report D-146-2013, exactly as published.
Show all FDA fields
- City
- Herndon
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 64116
- Address
- 607 Herndon Pkwy Ste 110
- Address (line 2)
- Ste 110
- Code information
- Lot Number: EHAD Exp. 07/14
- Postal code
- 20170-5477
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-146-2013
- Classification
- Class III
- Recalling firm
- Ascend Therapeutics Inc
- Product quantity
- 4, 835 bottles
- Termination date
- Jun 7, 2013
- Reason for recall
- Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***
- Distribution pattern
- Products were distributed nationwide.
- Recall initiation date
- Nov 19, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2013