ESTRONE recalled over manufacturing violations

Recall date

April 3, 2017

Source

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

Official notice title

Medisca, Inc. recalls ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d)…

Recall number

D-0664-2017

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

ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891