This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled one lot of lamotrigine ODT 200mg orally disintegrating tablets.
Why has lamotrigine ODT been recalled?
The recall was initiated because some lamotrigine ODT blister packs may be labeled incorrectly. The recalled batch may contain 100mg of lamotrigine instead of the 200mg labeled on the blister pack. This means that you may or may not be getting the full dose with each capsule. If you don’t receive the correct dose, your prescription may not be as effective.
When was the recall initiated?
The affected lots of lamotrigine ODT were recalled by the manufacturer on August 19th, 2016. These lots started shipping in in June 2016, so if you have leftover medication from before that date, yours would not be affected.
Are patients who have taken this medication being notified?
No. This is a class II recall, which means that it isn’t necessary to notify you unless your doctor believes it may have an effect on your health.
If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.
Which products were affected?
In this recall, 1 manufacturer, 1 lot, and 1 strength were affected. The recall will affect the following
Drug: Lamotrigine 200mg orally disintegrating tablet
Manufacturer: Impax Laboratories
National Drug Code (NDC): 00115-1529-08
If you have any trouble finding the lot and NDC information on your prescription, please check with your pharmacist for more information.