Why it was recalled
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: S16E02, Exp 05/18
Where it was sold
Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0378-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 17, 2017
- FDA report date
- Jan 23, 2019
- Quantity
- 5,000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Syntho Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0378-2019, exactly as published.
Show all FDA fields
- City
- Farmingdale
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81867
- Address
- 230 Sherwood Ave
- Code information
- Lot #: S16E02, Exp 05/18
- Postal code
- 11735-1718
- Report date
- Jan 23, 2019
- Product type
- Drugs
- Recall number
- D-0378-2019
- Classification
- Class II
- Recalling firm
- Syntho Pharmaceuticals, Inc.
- Product quantity
- 5,000 bottles
- Termination date
- Mar 27, 2020
- Reason for recall
- CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
- Recall initiation date
- Apr 17, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2019