Drug product
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
D-1519-2016
Product summary
- Event
- Event 75205
- Status
- Terminated
- Classification
- Class III
- Quantity
- 368 bottles
- Official record key
drug-enforcement:D-1519-2016
Official wording
Reason: Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Code information: Lot #: GLEH 16003, Exp 03/31/18
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.