Drug product
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
D-0111-2018
Product summary
- Event
- Event 78764
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9919 bottles
- Official record key
drug-enforcement:D-0111-2018
Official wording
Reason: Subpotent Drug
Code information: Lot #: 170029A, Exp. 02/2019; 170030A, Exp. 02/2019
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent