openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
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drug · product 1 of 1
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
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
These labels are deterministic app interpretations, not FDA categories.
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Reason for recall
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Code information
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
Distribution pattern
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
