Recalls / Class III
Class IIID-0543-2024
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
- 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 #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
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
- 13,440 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-0543-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.