Osmotica Pharmaceutical Corp
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0581-2018 | Class III | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trige | February 28, 2018 |
| D-0110-2018 | Class III | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trig | December 18, 2017 |
| D-0111-2018 | Class III | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trige | December 18, 2017 |
| D-1067-2013 | Class III | Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count b | September 16, 2013 |