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
Reported: June 12, 2024 Initiated: May 16, 2024 #D-0542-2024
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications.
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 21,360 units
- Distribution
- Nationwide within the United States
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 21,360 units.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 12, 2024. Severity: Low. Recall number: D-0542-2024.
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