Pharmacy Services

Campral® (Acamprosate) Recall - Tablets Failed Dissolution Test

March 22, 2012

Forest Pharmaceuticals, Inc. has voluntarily recalled several lots of Campral® (acamprosate) 333 mg tablets due to failing acid-stage dissolution tests. The affected tablets may increase risk for gastrointestinal adverse events including nausea, vomiting, and epigastric pain. The following lots have been recalled:

Product NDC # Lot # Expiration Date
Campral 333 mg DosePk 0456333060 1069783 4/30/2012
1082538 1/31/2013
1079546 1/31/2013
Campral 333 mg HUD 0456333063 1071614 4/30/2012
1072823 10/31/2012
1077653 1/31/2013
1078959 1/31/2013

Stop dispensing, distributing, and using the affected products immediately. Instructions and return forms for the affected product have been sent to distributors and retailers. Physician offices with affected Campral® samples have been sent a separate letter with details on the recall.

Return all affected products to:

 Forest Pharmaceuticals,Inc.
 ATTN: Recall Coordinator
 13600 Shoreline Dr.
 Earth City, MO 63045

Contact Forest Pharmaceuticals’ Customer Service Department at 800-678-1605 x 66298 for help with shipping the affected product, or select option 3, followed by option 5 for more information about the recall. Contact Forest Pharmaceuticals’ Medical Information and Communication Department for medical questions at 800-678-1605 x 66297.

Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm) and to Forest Pharmaceutical’s Drug Safety Department at 800-678-1605 x 66296.

Additional information is available at the following link:

Updated
March 22, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.