Reported Jul 5, 2017 · Terminated
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven…
Noven Pharmaceuticals, 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: Noven Pharmaceuticals, Inc. · 11960 SW 144th St · Miami, FL · 33186-6109
Is this the product you have?
- Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist
- byNoven Therapeutics, LLC. Miami, Florida 33186
- NDC68968-6610-8
- Lot codes and dates
Lot #:: 78618Exp. 05/2017
- Amount recalled
- 14434 cartons
Where it was sold
- Nationwide
Why it was recalled
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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