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

Recall Number: D-0378-2019

Firm: Syntho Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20190123

Initiation Date: 20170417

Termination Date: 20200327

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

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