Medisca, Inc. recalls ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 3877
Recalled April 19, 2017 · FDA recall D-0665-2017 · Medisca
Hazard
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection · FDA Class II
Units
N/A
Sold at
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Description
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Product
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
Manufacturer(s)
Medisca, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →