Reported Jun 19, 2019 · Terminated
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only,…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only
- Manufactured byGlenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India
- Manufactured forGlenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
- Lot codes and dates
Lot#: 20180516Exp 4/30/2020
- Amount recalled
- 31,656 boxes
Where it was sold
- Nationwide
Why it was recalled
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
This product could cause temporary or reversible health problems — stop using it.
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