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 Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by M…

Recall number

D-0666-2017

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 Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261