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Multiple Hormone Drugs Recalled


April 28, 2017

Medisca, Inc, voluntarily issued extensive, Class II recalls of several lots of its ESTRADIOL, USP Bulk (Hemihydrate), ESTRADIOL, USP (Hemihydrate) (Micronized), ESTRONE, USP Bulk, and ESTRIOL, USP (Micronized) Bulk, products.

The recalls, all of which are ongoing and affect products distributed throughout the United States, Australia, Bahamas, Italy, Singapore, Thailand, and the United Kingdom, were initiated by Medisca on April 3, 2017, on account of Current Good Manufacturing Practice deviations.

The following products and lots are being recalled:

  • ESTRADIOL, USP Bulk (Hemihydrate)
    • 25-g bottles (NDC 38779-2261-04)
      • Lot numbers 129669/C, 129669/F, 129669/H, 129669/J, 130941/B 130941/D, 130941/F, 136108/B, and 139091/B
    • 100-g bottles (NDC 38779-2261-05)
      • Lot numbers 129669/B, 129669/E, 130941/A, 130941/C, 130941/E, 130941/G, and 136108/A
  • ESTRADIOL, USP (Hemihydrate) (Micronized)
    • 100-mg bottles (NDC 38779-0869-07)
      • Lot number 137169/F
    • 1-g bottles (NDC 38779-0869-06)
      • Lot numbers 129670/G, 129670/K, 130942/G, 130942/L, 131429/G, 131430/G, and 137169/E
    • 5-g bottles (NDC 38779-0869-03)
      • Lot numbers 129670/F, 129670/J, 130942/F, 130942/K, 131429/F, 131430/F, and 137169/D
    • 10-g bottles (NDC 38779-0869-01)
      • Lot numbers 129670/E, 129670/I, 130942/E, 130942/J, 131429/E, 131430/E, and 137169/C
  • 25-g bottles (NDC 38779-0869-04)
    • Lot numbers 129670/D, 129670/H, 130942/D, 130942/I, 131429/D, 131430/D, 131430/H, and 137169/B
  • 100-g bottles (NDC 38779-0869-05)
    • Lot numbers 129670/C, 130942/C, 130942/H, 131429/C, 131430/C, 137169/A, and 137169/F
  • 500-g bottles (NDC 38779-0869-08)
    • Lot numbers 129670/B, 130942/B, 131429/B, and 131430/B
  • 1-Kg bottles (NDC 38779-0869-09)
    • Lot numbers 129670/A, 130942/A, 131429/A, and 131430/A
  • ESTRONE, USP Bulk
    • 100-mgs bottles (NDC 38779-0891-05)
      • Lot numbers 124880/D, 124880/O, 130940/J, and 135312/E
    • 1-gram bottles (NDC 38779-0891-06)
      • Lot numbers 124880/C, 124880/F, 124880/I, 124880/N, 130940/D, 130940/I, 135312/D, 135312/I, 136546/D, and 139489/B
    • 5-gram bottles (NDC 38779-0891-03)
      • Lot numbers 124880/B, 124880/H, 124880/M, 130940/C, 130940/H, 135312/C, 135312/H, and 136546/C
    • 25-gram bottles (NDC 38779-0891-04)
      • Lot numbers 124880/A, 130940/B, 130940/G, 135312/B, 135312/G, 136546/B, and 139489/A
  • 100-gram bottles (NDC 38779-0891-09)
    • Lot numbers 124880/G, 124880/J, 124880/L,130940/A, 130940/F, 135312/A, 135312/F, and 136546/A
  • ESTRIOL, USP (Micronized) Bulk
    • 5-gram bottles (NDC 38779-0732-03)
      • Lot numbers 126317/D, 126317/F, 127288/C, 127296/D, 136212/C, 137155/C, 137156/C, 138638/C, 138646/B, 138646/E, and 138646/I
    • 25-gram bottles (NDC 38779-0732-04)
      • Lot numbers 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D, and 138646/H
    • 100-gram bottles (NDC 38779-0732-05)
      • Lot numbers 126317/B, 127288/A, 127296/B, 136212/A, 137155/A, 137156/A, 138638/A, 138646/C, 138646/G, and 141219/A
    • 1-Kg bottles (NDC 38779-0732-09)
      • Lot numbers 126317/A, 127296/A, and 138646/F

The US Food and Drug Administration (FDA) stated in its Enforcement Report for the week of April 19, 2017, that the “manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection.”

The recalls were given Class II designations by the FDA on April 12, 2017.

—Meredith Edwards White

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