Osmotica Pharmaceutical Corp

FDA Regulatory Profile

Osmotica Pharmaceutical Corp appears in FDA public data with 4 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0581-2018, Class III) was initiated on February 28, 2018.

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0581-2018Class IIIMethylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, TrigeFebruary 28, 2018
D-0111-2018Class IIIMethylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, TrigeDecember 18, 2017
D-0110-2018Class IIIMethylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, TrigDecember 18, 2017
D-1067-2013Class IIIVenlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bSeptember 16, 2013