D-1519-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 5, 2016
- Initiation Date
- August 19, 2016
- Termination Date
- February 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 368 bottles
Product Description
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.
Reason for Recall
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Distribution Pattern
Nationwide
Code Information
Lot #: GLEH 16003, Exp 03/31/18