D-0543-2024 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 12, 2024
- Initiation Date
- May 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,440 units
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25