Drug product
Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
D-66403-003
Product summary
- Event
- Event 66403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,140 bottles
- Official record key
drug-enforcement:D-66403-003
Official wording
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Code information: Lot #: a) 2003194, 2003195; b) 2003193
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations