Key Takeaway

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by Impax Laboratories, Inc. was recalled on August 19, 2016. The hazard: Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

FDA Drug Class I Terminated

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed

Recalled: August 19, 2016 ~3,074 boxes (30 count boxes) units affected D-0215-2017

Description

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA

Hazard / Reason

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

Class I: Dangerous or defective product that could cause serious health problems or death.

Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.

Products Affected

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed

Drugs

Company Information

Impax Laboratories, Inc.

Hayward, CA, United States

View all 5 recalls by Impax Laboratories, Inc. →

Distribution

Distributed Nationwide

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FDA Drug Class III

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FDA Drug Class II

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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.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.