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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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