Recalls / Class III
Class IIID-0542-2024
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
- Brand name
- Estradiol
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Transdermal
- NDCs
- 70710-1191, 70710-1192, 70710-1193, 70710-1194, 70710-1195
- FDA application
- ANDA206241
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 21,360 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-05-16
- FDA classified
- 2024-06-06
- Posted by FDA
- 2024-06-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0542-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.