FDA recall D-0215-2017

Product

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

Reason for recall

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

Distribution

Distributed Nationwide

Key facts

Status

Terminated

Initiation date

2016-08-19

Report date

2016-12-28

Termination date

2017-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hayward, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0215-2017