Reported Jan 23, 2019 · Terminated

EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured…

Syntho Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Syntho Pharmaceuticals, Inc. · 230 Sherwood Ave · Farmingdale, NY · 11735-1718

Is this the product you have?

  • EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only
  • Manufactured BySyntho Pharmaceuticals, Inc., Farmingdale, NY 11735
  • Distributed ByCreekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
Lot codes and dates
    • Lot #: S16E01
    • Exp 05/18
Amount recalled
5,000 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 27, 2020 · Data as of Sep 19, 7:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.