Syntho Pharmaceuticals, Inc. recalls EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured
Recalled January 23, 2019 · FDA recall D-0377-2019 · Syntho Pharmaceuticals
Hazard
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. · FDA Class II
Units
5,000 bottles
Sold at
Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
Description
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Product
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
Manufacturer(s)
Syntho Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →