US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 17, 2017 (9 years ago)

EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
Syntho Pharmaceuticals, Inc.
NDC code
15310-010-01
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0378-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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