FDA-Drug2016-10-05Class III
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.
Unichem Pharmaceuticals Usa Inc
Hazard
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Sold states
Nationwide
Affected count
368 bottles
Manufactured in
777 Terrace Ave, Suite 102, Hasbrouck Heights, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1519-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief