Syntho Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
9
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0377-2019Class IIEEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, RxApril 17, 2017
D-0378-2019Class IIEEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx onlyApril 17, 2017