Drug product
LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
D-0378-2015
Product summary
- Event
- Event 66607
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,993 cartons
- Official record key
drug-enforcement:D-0378-2015
Official wording
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Code information: Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations