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
Check against the official notice below — it lists the full affected range.
Glenmark Pharmaceuticals Inc., USA is recalling Estradiol Vaginal Inserts, USP, 10 mcg in both 8-count and 18-count cartons due to a defective delivery system. Customers reported that the plunger on the applicator malfunctions. The recall affects approximately 96,240 applicators distributed to 5 retailers and 4 distributors across the United States, with multiple lot numbers affected and expiration dates ranging from December 31, 2019 through February 29, 2020.
The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Reason for recall: Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator Distribution: Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product. Quantity: 96,240 applicators Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.