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Hormone Inserts Recalled


March 29, 2018

Defective packaging has prompted Teva Pharmaceuticals to recall numerous lots of estradiol vaginal inserts, USP, 10 mcg, according to the March 28, 2018, US Food and Drug Administration (FDA) Enforcement Report. Customers complained of difficulty dispensing tablets from applicators.

The recall affects the following products and lots, which were distributed in the United States and Puerto Rico:

  • estradiol vaginal inserts packaged as 8 inserts per carton (NDC 0093-3223-08) from lots 33812545A, 33812546A, and 33812774A (Exp. 12/18); 33812775A (Exp. 1/19); 33812776A and 33812777A (Exp. 5/19); 33813786A and 33813868A (Exp. 7/19); 33813974A and 33814058A (Exp. 9/19); and 33814113A (Exp. 01/2019); and
  • estradiol vaginal inserts packaged as 18 inserts per carton (NDC 0093-3223-97) from lots 33812547A, 33813361A, and 33813676A (Exp. 1/19).

Teva Pharmaceuticals voluntarily initiated the recall March 19, 2018. At press time, the FDA had not yet issued a recall classification.

Estradiol vaginal is a prescription hormone tablet used to reduce vaginal symptoms of menopause.

Jolynn Tumolo


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