Drug 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.
D-0620-2018
Product summary
- Event
- Event 79542
- Status
- Terminated
- Classification
- Class II
- Quantity
- 640,486 vaginal inserts
- Official record key
drug-enforcement:D-0620-2018
Official wording
Reason: Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
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
Distribution pattern: Distributed within the United States and Puerto Rico.
Derived failure modes
-
Unknown
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.