Class II
Terminated
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
This recall has been terminated (originally issued January 16, 2019).
- Recall Initiated
- December 26, 2018
- Posted
- January 16, 2019
- Recall Number
- D-0350-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 96,240 applicators
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
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.
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
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