Drug product
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***
D-146-2013
Product summary
- Event
- Event 64116
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4, 835 bottles
- Official record key
drug-enforcement:D-146-2013
Official wording
Reason: Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Code information: Lot Number: EHAD Exp. 07/14
Distribution pattern: Products were distributed nationwide.
Derived failure modes
-
Unknown
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.