FDA recall D-0378-2019

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-04-17

Report date

2019-01-23

Termination date

2020-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Farmingdale, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0378-2019