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
Reported: January 16, 2019 Initiated: December 26, 2018 #D-0350-2019
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
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 96,240 applicators
- Distribution
- Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 96,240 applicators.
Why was this product recalled? ▼
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 16, 2019. Severity: Moderate. Recall number: D-0350-2019.
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