martes, 30 de agosto de 2016

FDA MedWatch - Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards

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Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards

AUDIENCE: Pharmacy, Patient
ISSUE: Impax Laboratories, Inc. issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg, NDC 0115-1529-08, Lot # 502240. The affected lot was distributed between June 13, 2016 and August 10, 2016 to wholesale distributors and retail pharmacies nationwide. 
Unit-of-use blister packs (a 10 count blister card contained in a single plastic shell-pack) may contain 100 mg product instead of 200 mg product.  Each blister card within the unit-of-use blister pack is properly labeled as 100 mg ODT, however the plastic shell pack containing the 100 mg blister cards is labeled as 200 mg ODT. Shell-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. 
BACKGROUND: Lamotrigine is indicated for the treatment of epilepsy or bipolar disorders. The lot number can be found on the side of the manufacturer’s carton as well as on the blister cards within the unit-of-use blister packs. See the press release for product label photos.
RECOMMENDATION: Consumers are being asked to carefully inspect their medication.  If they have the affected lot or any questions or concerns regarding this recall they should contact Stericycle at 1-866-300-2207 (Monday through Friday 8:00 a.m. through 5:00 p.m. EST).  Consumers who are unsure if they have the affected lot number or have any concerns about their product should consult their pharmacy or health care professional.
Pharmacists and wholesalers are being asked to check their inventories for the affected lot, segregate any material from the lot, and to then contact Stericycle at 1-866-300-2207 for instructions on product return. Pharmacies that received the affected lot will receive a copy of this press release with their recall notification information to be prominently posted in the pharmacy area.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the press release, at:

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