Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 20180516, Exp 4/30/2020
- 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: Estradiol Vaginal Inserts USP plunger is not functioning properly.
- 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, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Product Codes/Lot Numbers:
Lot#: 20180516, Exp 4/30/2020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1340-2019
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Cross Contamination with Other Products
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Failed Impurities/Degradation Specifications