Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

  • Criminal Investigations

    -

    Shire Pharmaceuticals Notification about Stolen Carbatrol Appearing as Expired Returns

    FDA posts press releases and other notices from firms as a service to consumers, the media, and other interested parties.    

    Shire Pharmaceuticals
    North American Headquarters
    725 Chesterbrook Boulevard
    Wayne, PA 19087

    August 17, 2010

    RE: Stolen Product

    Dear Trade Partner:

    On October 17, 2008 a shipment of Carbatrol and Adderall XR that was travelling from Shire’s manufacturing facility in North Carolina to Shire Distribution Center, Florence, Kentucky was stolen. Shire took immediate action and informed the local police and the DEA office. It has come to our attention that Carbatrol from the stolen lots has started to appear in our expired returns and more stolen product may still be on the market. As a result, Shire will not be issuing credit for these returns or any future returns of any of the stolen products referenced below.

     
    The following products and lot numbers are affected:  

     

    The following products and lot numbers are affected: Item #
    Product
    Lot Number
    Capsules per bottle
    Quantity
    Expiry Date
    2385012
    Adderall XR 15 mg
    A38146A
    100
    10,713
    02/29/2012
    2172127
    Carbatrol 200 mg
    A40918A
    120
    11,640
    04/30/2010
    2172127
    Carbatrol 200 mg
    A40919A
    120
    11,205
    04/30/2010
    2172127
    Carbatrol 200 mg
    A41575A
    120
    11,652
    05/31/2010


    Stolen Carbatrol and Adderall XR (the lot of Adderall XR is still within expiry) should not be used or sold because the safety and effectiveness of the product could have been compromised by improper storage and handling or tampering while outside of the legitimate supply chain. 
    For questions regarding disposition of the affected product, please contact the FDA’s Office of Criminal Investigations at 1-800-551-3989. The Agency is also asking for the public’s help in reporting any information regarding the stolen Carbatrol or Adderall XR, including suspicious or unsolicited offers for these products, by contacting OCI at the above number, or by visiting the OCI website at www.fda.gov/oci.
     
    Please update your system to reflect this information. If you have any questions or concerns regarding this notification, please feel free to contact Melisa Alimardani, Senior Trade Relations Specialist, at 1-800-828-2088 ext. 258777 or Shire’s Trade Account Team at 1-800-828-2088 option 5.

         Sincerely,
    Mark Kuhl
     

     

         Mark Kuhl

         Vice President, Managed Markets

     

    -
    -