Drug product
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
D-0581-2018
Product summary
- Event
- Event 79365
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19,664 100-bottles
- Official record key
drug-enforcement:D-0581-2018
Official wording
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.
Code information: Lots: 170231B, 170232A, 170233A, 170234A
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent