Estradiol Transdermal System Delivers 0.0375 mg/day recall
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven…
Why was Estradiol Transdermal System Delivers 0.0375 mg/day recalled?
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 #: 88321 Exp. 02/2022
- Product
- Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven…
- Recalling firm
- Noven Pharmaceuticals Inc
- Quantity
- 10872 cartons
- Distribution
- Nationwide within the United States
- Recall date
- April 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)