EEMT 1 recalled over manufacturing violations

Recall date

April 17, 2017

Source

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

Official notice title

Syntho Pharmaceuticals, Inc. recalls EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By:…

Recall number

D-0378-2019

FDA classification

Class II

Brand / firm

Syntho Pharmaceuticals, Inc.

Sold / distributed

Product was sold to the firm's sole distributor who further distributed the product throughout the United States.

Why it was recalled

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

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

What was recalled

EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01