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.

UK Recalls Multiple Generic Drugs

Violations of European standards by an outsourced Indian manufacturer have prompted the recall of multiple generic drugs in the United Kingdom.

Novartis's generics unit was one of about eight companies that recalled drugs this week because of "serious" deficiencies in so-called good manufacturing practices found during inspections of the contract manufacturer, MJ Biopharm, in India, according to the U.K. Medicines and Healthcare Products Regulatory Agency.

Novartis generic unit, Sandoz recalled fluoxetine, an antidepressant which is the generic version of Eli Lilly’s Prozac. Other drugs recalled by Sandoz included Baclofen for muscle spasms, and metformin for diabetes.

Other recalled drugs included hypertension pills amlodipine and doxazosin and pain-reliever naproxen. The other companies that recalled drugs included Strandhaven Ltd., LPC Medical Ltd., Karib Kemi Pharm Ltd., Milpharm Ltd., Greystone Ltd., Jubilant Pharmaceuticals NV and Wockhardt UK Ltd.

To view the entire article visit the Wall Street Journal Online at: www.wsj.com.

Ranbaxy Probed Over Counterfeit Medicine

In an article that appeared in the Washington Times, the Justice Department is investigating whether Ranbaxy Laboratories Ltd., which supplies generic drugs to the U.S. market and to President Bush's global AIDS initiative, has falsified data, followed sub-par manufacturing practices and distributed counterfeit medicine.

The filing stated that "allegations from reliable sources indicate a pattern of systematic fraudulent conduct" by the company. The allegations include that in its application process, the company submitted fabricated data to the Food and Drug Administration for generic drugs to be distributed in the U.S. and anti-retroviral drugs to be distributed in other countries as part of the President's Emergency Plan for AIDS Relief.

This is yet another example of potentially counterfeit product distributed widely in the global pharmaceutical supply chain that would have passed all Track and Trace methods of interdiction. These products have been distributed and consumed because pedigree or tracing processes do not authenticate the medication inside the container.

XStream Systems XT250 would have been able to discover the fraudulent and counterfeit material before they were distributed and dispensed because the technology verifies the molecular structure of the medication inside the sealed container.

To learn more about the XT250, visit our website at www.xstreamsystems.net.

To read more of the Washington Times article click here.

Ranbaxy; More Concern over Substandard Medications

This year of 2008 should go down in the history books as the year of drug safety concerns. The latest concerns are over FDA accusations that Ranbaxy Laboratories sold substandard drugs and knowingly concealed the facts.

Ranbaxy is one of India’s largest generic manufacturers and 25% of their sales are in the U.S. They have been accused of using raw materials from unapproved sources in one of their northern India plants and altering in-house testing to meet FDA standards which resulted in sub-potent, super-potent or adulterated products.

"The government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products" into the US market, federal prosecutors said.

This coupled with earlier cases this year of adulterated heparin from China, has left consumers doubting the safety of their medications. Most troubling is that the current methods being considered would not be effective in verifying the validity or purity of the drug itself.

Incidents such as this illustrate the need for an authentication of the product as a way to protect all of the members of the Pharmaceutical Supply Chain and most importantly the consumer. Track and Trace technologies (pedigrees and RFID) will not protect the consumer from these types of incidents which we can expect to happen more frequently as we continue to increase our reliance on global sources for our medications. Only XStream Systems’ XT250 has the solution to authenticating the product inside the sealed container. This is the only solution to this clear and present danger.