Reported Jan 16, 2019 · Terminated
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC…
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, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons
- Manufactured byGlenmark Pharmaceuticals, Ltd., Colvale, Goa India
- Manufactured forGlenmark Pharmaceuticals, Inc., USA Mahwah, NJ
- Lot codes and dates
- Batch numbers
a) 20180393exp. date 01/31/202020180424exp. date 02/29/202020180425exp. date 02/29/202020180427exp. date 02/29/2020b) 20180338exp. date 12/31/201920180386exp. date 01/31/2020
- Batch numbers
- Amount recalled
- 96,240 applicators
Why it was recalled
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
This product could cause temporary or reversible health problems — stop using it.
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