Reported Jun 12, 2024 · Ongoing
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited,…
Zydus Pharmaceuticals (USA) Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only
- Manufactured byCadila Healthcare Limited, Ahmedabad, India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
- Lot codes and dates
Lot #: M310493Exp. Date 01/2025M308397Exp. Date 11/2024M305337Exp. Date 10/2024M400155Exp. Date 06/2025M314660Exp. Date 05/2025
- Amount recalled
- 21,360 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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