FDAFDA · Food and drugs·Recall number D-0620-2018
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.
Published March 28, 2018 · Recall initiated: March 19, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESTRADIOL
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Distributed within the United States and Puerto Rico.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.