LAMOTRIGINE
Generic: LAMOTRIGINE
Unichem Pharmaceuticals (USA)Manufacturer
ORALRoute
LAMOTRIGINEActive Substance
2011-10-06Original Approval
LAMOTRIGINE is FDA application ANDA090170, sponsored by UNICHEM LABS LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class I2019-12-20
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, IsCross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class III2020-05-28
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III2016-08-19
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., PiTablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Class II2018-09-11
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PFailed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5
Class III2022-07-20
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 4229Labeling: Label Error on Declared Strength
Top Reported Reactions
1
DRUG INEFFECTIVE
6,209 reports
2
SEIZURE
4,294 reports
3
TOXICITY TO VARIOUS AGENTS
3,929 reports
4
OFF LABEL USE
3,471 reports
5
DRUG INTERACTION
3,257 reports
6
COMPLETED SUICIDE
3,072 reports
7
FATIGUE
2,989 reports
8
DIZZINESS
2,981 reports
9
NAUSEA
2,969 reports
10
RASH
2,875 reports