ESTRADIOL recalled over manufacturing violations

Recall date

April 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 387…

Recall number

D-0665-2017

FDA classification

Class II

Brand / firm

Medisca, Inc.

Sold / distributed

Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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