Status
Terminated
Drug Enforcement D-146-2013
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Classification
Class III
Report Date
February 13, 2013
Termination Date
June 7, 2013
Product Information
- 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***
- Product quantity
- 4, 835 bottles
- Reason for recall
- Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Products were distributed nationwide.
Location & Firm
- Recalling firm
- Ascend Therapeutics Inc
- Address
-
607 Herndon Pkwy Ste 110, Ste 110
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-146-2013
- Event ID
- 64116
- Recall initiation date
- November 19, 2012
- Center classification date
- February 4, 2013
- Code info
- Lot Number: EHAD Exp. 07/14
- More code info
- —