FDA-Drug2019-01-23Class II
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
Syntho Pharmaceuticals, Inc.
Hazard
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Sold states
Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
Affected count
5,000 bottles
Manufactured in
230 Sherwood Ave, Farmingdale, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0377-2019Don't want to check this manually?
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