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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Information Notice on Certain Stolen Pharmaceutical and Consumer Health Products from GlaxoSmithKline

 

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

 

GlaxoSmithKline is working with U.S. Food and Drug Administration, Office of Criminal Investigations, the Atlanta District Office (FDA), and other law enforcement officials to recover product that was stolen while being transported from the distributor to wholesalers in the Bayamon district of Puerto Rico on January 29, 2010.  The products and quantities stolen are listed below.  In every instance, the stolen product represents a very small portion of each product lot.

 

           

NDC

Description

Lot #

Quantity

(Unit of Sale)

0173-0697-00

Advair Diskus 500/50mcg 60 Dose

9ZP2144

2

0007-5500-40

Albenza 200mg 112s

9B001

4

0007-3152-13

Avandaryl 4mg/2mg 30s

9ZP2540

48

0029-3159-00

Avandia 4mg 90s

9ZP2237

48

0029-1527-22

Bactroban Cream 15gm

C433259

160

0007-4139-20

Coreg 3.125 100s

MTSR1212

4

0007-3370-13

Coreg CR 10mg 30s

9ZP4771

96

0007-3371-13

Coreg CR 20mg 30s

9ZP0413

95

0007-3372-13

Coreg CR 40mg 30s

9ZP3661

224

0007-3373-13

Coreg CR 80mg 30s

9ZP3920

16

0173-0201-55

Daraprim 25mg 100s

A44519

3

0173-0470-01

Epivir 150mg 60s

9F004

3

0173-0470-01

Epivir 150mg 60s

9K007

9

0173-0662-00

Epivir HBV 100mg 60s

9D003

1

0173-0471-00

Epivir Oral 10mg/ml 240ml

9E003

12

0173-0719-20

Flovent HFA 110mcg 120 Actuation

F0638

48

58160-825-51

Havrix 720 ELU Tip Lok 10s

AHAVB371BA

1

0173-0260-35

Lanoxin Inj 0.5mg/2ml 50s 

8M920

2

0173-0713-25

Myleran 2mg 50s

809980

1

0007-4883-13

Requip XL 6mg 30s

9ZP3419

2

0173-0750-00

Treximet 85mg/500mg 9s

8ZP2362

60

 

 

In addition to the prescription products listed above, certain lots of retail-ready consumer healthcare products were also involved in the theft.  The products stolen were full cases of a wide variety of products, including Tums antacid, Sensodyne toothpaste and Poligrip Denture Adhesive and Ecotrin aspirin.  In every instance, the stolen product represents a very small portion of each product lot.

 

GlaxoSmithKline, along with FDA and local authorities, has initiated efforts to locate the stolen product and identify the individuals who were involved in the theft.

 

Anyone who has information regarding this incident or has received suspicious or unsolicited offers for the product in question after the date of the theft is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or by visiting the OCI Web Site (http://www.fda.gov/OCI).  Patient or customer inquiries for the company should be directed to GSK’s Customer Response Center at 1-888-825-5249.

 

GlaxoSmithKline products are delivered in tamper-evident packages or appropriate packaging to protect product integrity.  GSK and the FDA advise physicians, retailers, and consumers to check all products for signs of tampering or damage prior to use.  Do not use the product if the packaging appears to have been disturbed in any way.  It is always advisable to purchase product only from trusted and reliable sources and to be aware that an unusually low price may be an indication that the product has been stolen.

 

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.