ESTRIOL recalled over manufacturing violations

Recall date

April 3, 2017

Source

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

Official notice title

Medisca, Inc. recalls ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC…

Recall number

D-0663-2017

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

ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732