FDAFDA · Food and drugs·Recall number D-0350-2019
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 by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ
Published January 16, 2019 · Recall initiated: December 26, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESTRADIOL VAGINAL INSERTS
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
- UPC
- 0368462711880
- Lot
- Batch numbers: a) 20180393, exp. date 01/31/2020, 20180424, exp. date 02/29/2020, 20180425, exp. date 02/29/2020, 20180427, exp. date 02/29/2020; b) 20180338, exp. date 12/31/2019, 20180386, exp. date 01/31/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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