Key Takeaway
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 Phar by Unichem Pharmaceuticals Usa Inc was recalled on August 19, 2016. The hazard: Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
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 Phar
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.
Hazard / Reason
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Class III: Product that is not likely to cause adverse health consequences.
Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.
Products Affected
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 Phar
DrugsCompany Information
Unichem Pharmaceuticals Usa Inc
Rochelle Park, NJ, United States
View all 11 recalls by Unichem Pharmaceuticals Usa Inc →Distribution
Nationwide
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.