FDAFDA · Food and drugs·Recall number D-0378-2019
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
Published January 23, 2019 · Recall initiated: April 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Syntho Pharmaceuticals, Inc.
- Distributor
- Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
- Lot
- Lot #: S16E02, Exp 05/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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