On August 19, Impax Laboratories, Inc. issued a voluntary nationwide recall for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg, a treatment that is indicated for the treatment of epilepsy and bipolar disorders.
| NDC Number | Blister Pack | Lot Number |
|---|---|---|
| 0115-1529-08 | 30 | 502240 |
According to the press release, the affected lot was distributed “between June 13, 2016 and August 10, 2016 to wholesale distributors and retail pharmacies nationwide.”
About the affected product:
- One unit-of-use blister packs is a 10 count blister card contained in a single plastic shell-pack (200 mg)
- These unit-of-use blister packs may contain 100 mg product (instead of 200 mg product)
- Each blister card is properly labeled (as 100 mg ODT)
- The plastic shell pack containing the 100 mg blister cards is labeled as 200 mg ODT
According to the FDA, “[s]hell-packs from the affected lot may contain 100 mg ODT instead of 200 mg ODT, and as a result, it is possible that consumers could take less than their intended lamotrigine dose. A reduction in dose may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.”
The FDA is asking consumers to “carefully inspect their medication.”
For more information about this recall, click here.
Photo courtesy of the FDA.
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