Why it was recalled
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
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-0350-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 26, 2018
- FDA report date
- Jan 16, 2019
- Quantity
- 96,240 applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0350-2019, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81876
- Address
- 750 Corporate Dr
- 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
- Postal code
- 07430-2009
- Report date
- Jan 16, 2019
- Product type
- Drugs
- Recall number
- D-0350-2019
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 96,240 applicators
- Termination date
- Oct 6, 2020
- Reason for recall
- Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
- Recall initiation date
- Dec 26, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2019