Teva Pharmaceuticals USA: 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. Subs

Is my product affected?

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.

• Brand ESTRADIOL

Check against the official notice below — it lists the full affected range.

What happened

Teva Pharmaceuticals USA is recalling Estradiol Vaginal Inserts, USP 10 mcg, in two package sizes: 8 inserts per carton (NDC 0093-3223-08) and 18 inserts per carton (NDC 0093-3223-97). The recall affects 640,486 vaginal inserts distributed in the United States and Puerto Rico due to complaints that the tablets are difficult to dispense from the applicator. Multiple lot numbers are affected with expiration dates ranging from December 2018 through September 2019.

The recall record does not specify what consumers should do regarding affected product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator. Distribution: Distributed within the United States and Puerto Rico. Quantity: 640,486 vaginal inserts Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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