Drug product
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
D-0543-2024
Product summary
- Event
- Event 94649
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 13,440 units
- Official record key
drug-enforcement:D-0543-2024
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications