HAYWARD, Calif., Aug. 26, 2016 /PRNewswire/ -- Impax
Laboratories, Inc. (NASDAQ: IPXL) announced today that the
Company had issued a voluntary nationwide retail level recall on
August 19, 2016 for one lot of
Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg. The
Company is issuing this press release to provide further heightened
awareness of this recall and to provide instructions to consumers,
pharmacists, and wholesalers in possession of the affected
product. Details related to the recalled product are set
forth below.
NDC
Number
|
Blister
Pack
|
Lot
Number
|
0115-1529-08
|
30
|
502240
|
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.
Lamotrigine is indicated for the treatment of epilepsy or
bipolar disorders. It is important for consumers to take the
dose of lamotrigine prescribed by their physicians. A reduction in
dose may lead to reduced therapeutic effects of lamotrigine and
reemergence of epilepsy or bipolar disorder symptoms.
The affected lot was distributed between June 13, 2016 and August
10, 2016 to wholesale distributors and retail pharmacies
nationwide. 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. Lamotrigine ODT 200 mg tablets are
off-white to white circular tablets, approximately 14 mm in
diameter, debossed with "WPI" on one side and "3724" on the other,
supplied in blisters of 10 (NDC 0115-1529-15) and in cartons of 30
(NDC 0115-1529-08).
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.
- Online:www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500
available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on
the pre-addressed form.
- Fax: 1-800-FDA-0178
This voluntary recall is being made with the knowledge of the
U.S. Food and Drug Administration.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical
company applying its formulation expertise and drug delivery
technology to the development of controlled-release and specialty
generics in addition to the development of central nervous system
disorder branded products. Impax markets its generic products
through its Impax Generics division and markets its branded
products through the Impax Specialty Pharma division. Additionally,
where strategically appropriate, Impax develops marketing
partnerships to fully leverage its technology platform and pursues
partnership opportunities that offer alternative dosage form
technologies, such as injectables, nasal sprays, inhalers, patches,
creams, and ointments.
Contacts:
Consumer:
1-866-300-2207
Media:
Mark Donohue
1-215-558-4526
Photo - http://photos.prnewswire.com/prnh/20160826/401865
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SOURCE Impax Laboratories, Inc.