Inspections, Compliance, Enforcement, and Criminal Investigations

Shire Pharmaceuticals Notification about Stolen Carbatrol Appearing as Expired Returns

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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:

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

Page Last Updated: 01/28/2015
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