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.

FDA recall notice · announced March 28, 2018 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.

Notes

Distribution: Distributed within the United States and Puerto Rico.
Lot/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
Quantity: 640,486 vaginal inserts
Status: Terminated
Products in this recall event:
- 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 Pharmaceuti (D-0620-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.