ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869

Reason: cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Code information: a) 137169/F b) 129670/G, 129670/K, 130942/G, 130942/L, 131429/G, 131430/G, 137169/E c) 129670/F,129670/J, 130942/F, 130942/K 131429/F, 131430/F, 137169/D, d) 129670/E, 129670/I,130942/E, 130942/J,131429/E, 131430/E, 137169/C e) 129670/D, 129670/H, 130942/D, 130942/I, 131429/D, 131430/D, 131430/H, 137169/B f) 129670/C, 130942/C, 130942/H, 131429/C, 131430/C, 137169/A, 137169/F g) 129670/B, 130942/B, 131429/B, 131430/B h) 129670/A, 130942/A ,131429/A, 131430/A

Distribution pattern: Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom