D-0350-2019 Class II Terminated
FDA drug recall D-0350-2019 was initiated by Glenmark Pharmaceuticals Inc., USA on Dec 26, 2018 and is designated Class II. Reason for recall: Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator The recall status is terminated (terminated Oct 6, 2020). Affected quantity: 96,240 applicators.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 16, 2019
- Initiation Date
- Dec 26, 2018
- Termination Date
- Oct 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96,240 applicators
Product Description
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
Reason for Recall
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Distribution Pattern
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0350-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026