Reported Nov 6, 2019 · Terminated
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton…
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 a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only
- Manufactured byGlenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India
- Manufactured forGlenmark Pharmaceuticals Inc., Mahwah, NJ 07430
- Lot codes and dates
- Batch numbers
a) 2018051420180544Apr-2020201805452018054620180588May-202020190003Jun-2020b) 2018051520180543Apr-202020180587May-2020
- Batch numbers
- Amount recalled
- 216,840 cartons
Where it was sold
- Nationwide
Why it was recalled
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
This product could cause temporary or reversible health problems — stop using it.
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