Estradiol Transdermal System recall: Impurity Out of Spec
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
Why was Estradiol Transdermal System recalled?
Failed Impurities/Degradation Specifications.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
- 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
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Quantity
- 13,440 units
- Distribution
- Nationwide within the United States
- Recall date
- June 12, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)