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Recall Enforment Report D-0110-2018

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Osmotica Pharmaceutical Corp, originally initiated on 12-18-2017 for the product Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10 The product was recalled due to subpotent drug. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0110-201812-18-201712-27-2017Class III10064 bottlesMethylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10Subpotent DrugTerminated
D-0111-201812-18-201712-27-2017Class III9919 bottlesMethylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10Subpotent DrugTerminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
13811-706Methylphenidate Hydrochloride Methylphenidate HydrochlorideTablet, Extended ReleaseOralTrigen Laboratories, LlcHuman Prescription Drug
13811-707Methylphenidate Hydrochloride Methylphenidate HydrochlorideTablet, Extended ReleaseOralTrigen Laboratories, LlcHuman Prescription Drug
13811-708Methylphenidate Hydrochloride Methylphenidate HydrochlorideTablet, Extended ReleaseOralTrigen Laboratories, LlcHuman Prescription Drug
13811-709Methylphenidate Hydrochloride Methylphenidate HydrochlorideTablet, Extended ReleaseOralTrigen Laboratories, LlcHuman Prescription Drug
13811-710Methylphenidate Hydrochloride Methylphenidate HydrochlorideTablet, Extended ReleaseOralTrigen Laboratories, LlcHuman Prescription Drug