D-0377-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 23, 2019
- Initiation Date
- April 17, 2017
- Termination Date
- March 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,000 bottles
Product Description
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
Reason for Recall
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Distribution Pattern
Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
Code Information
Lot #: S16E01, Exp 05/18