Why it was recalled
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Product description
Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.
Lot numbers, UPCs & expiration codes
Lot #: a) 33812545A, 33812546A, 33812774A, Exp. 12/2018; 33812775A, Exp. 01/2019; 33812776A, 33812777A, Exp. 05/2019; 33813786A, 33813868A, Exp. 7/2019; 33813974A, 33814058A, Exp. 09/2019; 33814113A, Exp. 01/2019; b) 33812547A, 33813361A,33813676A, Exp. 1/2019
Where it was sold
Distributed within the United States and Puerto Rico.
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-0620-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2018
- FDA report date
- Mar 28, 2018
- Quantity
- 640,486 vaginal inserts
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0620-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 79542
- Address
- 1090 Horsham Rd
- Code information
- Lot #: a) 33812545A, 33812546A, 33812774A, Exp. 12/2018; 33812775A, Exp. 01/2019; 33812776A, 33812777A, Exp. 05/2019; 33813786A, 33813868A, Exp. 7/2019; 33813974A, 33814058A, Exp. 09/2019; 33814113A, Exp. 01/2019; b) 33812547A, 33813361A,33813676A, Exp. 1/2019
- Postal code
- 19454-1505
- Report date
- Mar 28, 2018
- Product type
- Drugs
- Recall number
- D-0620-2018
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 640,486 vaginal inserts
- Termination date
- Oct 15, 2019
- Reason for recall
- Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.
- Distribution pattern
- Distributed within the United States and Puerto Rico.
- Recall initiation date
- Mar 19, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2018