Drug product
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
D-1204-2018
Product summary
- Event
- Event 80985
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,384 30-count bottles
- Official record key
drug-enforcement:D-1204-2018
Official wording
Reason: Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Code information: Lot: BFR5D002 EXP 11-2019
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Out of Specification