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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Glenmark Pharmaceuticals Inc., USA
- Reason for Recall:
- Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
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 Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0350-2019
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Glenmark Pharmaceuticals Inc., USA
Cross Contamination with Other Products
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Failed Impurities/Degradation Specifications