FDA recall D-0110-2018
Osmotica Pharmaceutical Corp · Class III · drug
Product
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
Reason for recall
Subpotent Drug
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-12-18
- Report date
- 2017-12-27
- Termination date
- 2019-05-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Marietta, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0110-2018