Drug recall
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen…
FDA recall event 78764 · Class III · Osmotica Pharmaceutical Corp
Key facts
| Event ID | 78764 |
|---|---|
| Recall numbers | D-0110-2018, D-0111-2018 |
| Recalling firm | Osmotica Pharmaceutical Corp |
| Product type | Drugs |
| Products | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10, Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent Drug |
| Initiation date | Dec 18, 2017 |
| Report date | Dec 27, 2017 |
| Termination date | May 1, 2019 |
| City | Marietta |
| State | GA |
| Country | United States |
| FEI number | 3009078927 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: