FDA-Drug2016-12-28Class I
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
Impax Laboratories, Inc.
Hazard
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Sold states
Distributed Nationwide
Affected count
3,074 boxes (30 count boxes)
Manufactured in
31153 San Antonio Street, N/A, Hayward, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0215-2017Don't want to check this manually?
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