Why it was recalled
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Product 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
Lot numbers, UPCs & expiration codes
Lot#: 20180516, Exp 4/30/2020
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1340-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 3, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 31,656 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-1340-2019, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83019
- Address
- 750 Corporate Dr
- Code information
- Lot#: 20180516, Exp 4/30/2020
- Postal code
- 07430-2009
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1340-2019
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 31,656 boxes
- Termination date
- May 2, 2022
- Reason for recall
- Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jun 3, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 11, 2019