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|
|Campral 333 mg HUD||0456333063||1071614||4/30/2012|
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:
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:
- Company Recall Letter:
March 22, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.