Drug product
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
D-0542-2024
Product summary
- Event
- Event 94649
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 21,360 units
- Official record key
drug-enforcement:D-0542-2024
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: M310493, Exp. Date 01/2025; M308397, Exp. Date 11/2024; M305337, Exp. Date 10/2024; M400155, Exp. Date 06/2025; M314660, Exp. Date 05/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications