Reported Jan 23, 2019 · Terminated
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By:…
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 (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only
- Manufactured BySyntho Pharmaceuticals, Inc., Farmingdale, NY 11735
- Distributed ByCreekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01
- Lot codes and dates
Lot #: S16E02Exp 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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