Drug product
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
D-0378-2019
Product summary
- Event
- Event 81867
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,000 bottles
- Official record key
drug-enforcement:D-0378-2019
Official wording
Reason: CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Code information: Lot #: S16E02, Exp 05/18
Distribution pattern: Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
Derived failure modes
-
Manufacturing or process control
CGMP deviations