Osmotica Pharmaceutical recalls
Osmotica Pharmaceutical appears in 4 official U.S. recall notices indexed by RecallRadar, most recently on 2018-03-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 4 |
|---|---|
| Published | 2013-10-09 to 2018-03-14 |
| By agency | FDA Drug (4) |
| By classification | Class III (4) |
| By status | terminated (4) |
| Distribution named in notices | US |
Recalls
- Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 088…
FDA Drug · Class III · 2018-03-14 · Osmotica Pharmaceutical
Reason: Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet. - Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08…
FDA Drug · Class III · 2017-12-27 · Osmotica Pharmaceutical
Reason: Subpotent Drug - Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08…
FDA Drug · Class III · 2017-12-27 · Osmotica Pharmaceutical
Reason: Subpotent Drug - Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-coun…
FDA Drug · Class III · 2013-10-09 · Osmotica Pharmaceutical
Reason: Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.