Showing posts with label dey. Show all posts
Showing posts with label dey. Show all posts

Friday, January 1, 2010

Pharmaceutical Cargo Theft Emerges as a Organized Criminal Activity in 2009


In an excellent online article written by Nick Basta in Pharmaceutical Commerce, he explores the expanding issue of pharmaceutical cargo theft and the ongoing efforts to fight against this problem which poses a serious threat to US healthcare consumers. This issue has become more public in 2009.

Basta writes an overview of the issue and covers various Pharma companies, transportation industry solutions and interviews various industry experts.

Highlighting the article were some of the more significant pharmaceutical cargo thefts in 2009:

  • Almost 36,000 cartons of albuterol sulfate vials from Dey L.P. (Napa, CA) stolen in early August in McKinney, TX. Dey sent out an announcement advising that “pharmacists are encouraged to verify pedigree documentation for all purchases of Dey-labeled” albuterol.
  • Teva Pharmaceuticals lost almost 1,000 cartons of Copaxone (glatiramer acetate) in a theft in April; Copaxone is a temperature-controlled product that must be stored below 74° F and out of sunlight; Teva had to recall the remainder of that lot.

  • Novo Nordisk lost 129,000 vials of Levemir (recombinant-DNA insulin) in a North Carolina robbery in the spring. In June, it and FDA announced that the product—which requires refrigerated storage—had shown up in a medical center in Houston; subsequently FDA reported that it “has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.” An August followup reported that the stolen insulin was still showing up and that only 2% of the vials had been accounted for.

  • The biggest-value recent theft—which didn’t produce an FDA alert because the product was recovered within minutes of being stolen, occurred along the PA Turnpike in May. An Eli Lilly shipment of insulin valued at $37 million was stolen (along with the truck) at a turnpike rest stop, but the truck was located a few miles down the road by quick-acting state troopers; the shipment was intact and allowed to proceed, according to industry sources.

To read the entire online story, Cargo Theft Emerges as New Biopharm Worry, in Pharmaceutical Commerce, visit: http://www.pharmaceuticalcommerce.com/frontEnd/1345-pharmaceutical_logistics_theft_in_transit_cargo_security_coalition.html.


To learn more about XStream Systems, onsite supply chain material screening solutions, visit: http://www.xstreamsystems.net/.

Sunday, September 13, 2009

Dey Labs: Update on Stolen Albuterol Sulfate Inhalation Solution

As posted on the FDA Website and as a service to those interested in combating fraudulent, adulterated and counterfeit medications, the following is an announcement from Dey Labs:

In keeping with its commitment to “Put Patients First,” Dey, L.P. (“Dey’) would like to take this opportunity to inform its healthcare partners regarding a recent occurrence of stolen medication.

On or about August 6, 2009, a truck tractor-trailer which was not affiliated with Dey, containing 35,760 cartons of Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials was stolen. The truck theft occurred in the town of McKinney Texas.

The tractor-trailer contained two (2) complete Lots of product, each identified with the Dey label and NDC number. The specific product information is as follows:

Product Description:Albuterol Sulfate Inhalation Solution 0.083% 30-vials per carton (Product NDC #49502-697-29)





OT #CARTON QUANTITY


Lot Expiration Date
9FE217,712


June 2011
9G0118,048


July 2011


These two Lot numbers were not available commercially prior to the theft. All of the product cartons in these two Lots were stolen. Therefore, no vial or carton of either Lot is part of the legitimate pharmaceutical supply chain.

Pharmacies are encouraged to verify pedigree documentation for all purchases of Dey labeled Albuterol Sulfate, 0.083%, 30-vial cartons and product with either of these two Lots numbers should not be sold, distributed or dispensed.

If you have any information regarding the theft of these two Lots, or if you receive any suspicious or unsolicited offers for the Albuterol in question, please contact the Food and Drug Administration (“FDA”) Office of Criminal Investigations (“OCI”) by calling 1-800-551-3989.

For Customer Service inquiries, contact Dey, L.P. Customer Service at 1-800-527-4278.

For medical or other clinically related inquiries about this matter, contact Dey’s Senior Vice President of Quality Systems at 1-800-755-5560, ext. 2476.

Tuesday, August 18, 2009

SafeMeds Alert: FDA Warns Healthcare Professionals and Public About Stolen Asthma Drug

Nearly 36,000 Cartons of Dey Brand Generic Albuterol Sulfate Inhalation Solution Stolen in Texas

SafeMed via their on-line and email alert system is sending out information on the FDA alert to patients and healthcare professionals regarding a cargo theft of 35,760 cartons of Dey brand generic Albuterol Sulfate Inhalation Solution that occurred on approximately August 5, 2009.

On August 7, 2009, it was reported that in McKinney, Texas, a tractor-trailer containing a 35,760-carton shipment of an asthma drug belonging to the RiteDose Corporation was stolen. The product in question is Albuterol Sulfate Inhalation Solution 0.083%. The NDC number is 49502-697-29. Each carton displays the brand name "DEY" and contains thirty 3ml single-dose vials. The lot numbers of the stolen product were "9G01" and "9FE2." These two lot numbers were not commercialized prior to the theft. All the product units in these lots were stolen. The product could represent a health risk because the required temperature-controlled supply chain may have been broken.

If you receive any offers for these stolen drug products or think that you may have been sold the stolen drug products referenced in this notice, FDA is asking your help in reporting this information to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site, http://www.fda.gov/ICECI/CriminalInvestigations/ucm123025.htm.

To learn more about SafeMed Alerts, go online at www.safemeds.org.