Showing posts with label Pharmacy. Show all posts
Showing posts with label Pharmacy. Show all posts

Thursday, January 16, 2014

FDA Seizes Hundreds of Rogue Pharmacy Websites.


Don't order medicines from web sites that claim to be Canadian pharmacies. Most are not legitimate pharmacies, and the drugs they supply are illegal and potentially dangerous.
Claiming to be a Canadian pharmacy is one of the hallmarks of Internet sites that sell illegal prescription drugs which, in many cases, are not made in Canada at all, but in a number of other countries. (Even if an online Canadian pharmacy is legitimate, in general, U.S. citizens cannot legally import prescription drugs from other countries. But that's a separate issue. We're talking here about fraud.)
There are many other false claims being made, but this one figured prominently in the June 2013 seizure of hundreds of rogue pharmacy websites.
This is according to Special Agent Daniel Burke, senior operations manager in FDA's Cybercrimes Investigations Unit, a special team created in March 2013 in the agency's Office of Criminal Investigations (OCI). Cybercrimes are illegal acts involving a computer and a network. This unit works with other domestic and international agencies to track down the operators and suppliers of websites that illegally sell prescription medicines. The agents' methods include high-tech detection in which they follow the cyber-trail of these pharmacies, and go undercover to infiltrate the criminal world.
Burke explains that medicines offered by these sites are often stolen or counterfeit. An unsuspecting consumer may be buying a medicine that does not have the active ingredient that will make it effective, or it may have undisclosed ingredients that could endanger their health or even be life-threatening.
"Consumers are able to buy prescription drugs, unapproved drugs and potentially counterfeit drugs without a full understanding of the risks that they take when they do that," says OCI Director John Roth. "What worries me is that people naively believe that these medicines are safe."
Illegal Pharmacy Websites Seized
In June, FDA—working with international regulatory and law enforcement agencies, including the U.S. Attorney's Office in Denver, Colorado—seized and shut down 1,677 illegal pharmacy websites. Many of the websites appeared to be operated by a criminal network that represented itself as various Canadian pharmacies.
The medicines sold on these websites were described as "brand name" or "FDA-approved" when they were neither. Products purchased by federal agents bypassed safety controls required by FDA, including that they be used with a valid prescription and under the supervision of a licensed health care provider.
Some of the illegal sites used the names of well-known U.S. retailers to trick consumers into believing that there was an affiliation with those stores. Examples include www.walgreens-store.com and www.c-v-s-pharmacy.com.
The banner of FDA's Cybercrimes Investigation Unit is now displayed on the seized sites to identify them as illegal.
Burke says it was dogged online detective work by federal investigators who monitored site traffic, "followed the money trail," and tracked the bogus sites back to an operation based overseas. An estimated 10,000 such sites are believed to be part of this network, he says. The U.S. investigators turned over their findings to local authorities via the international police organization Interpol.
Undercover Investigations
Burke estimates that there are 40,000 to 60,000 domain names that could be tied to illegal online pharmacies at any given time, and that this number is in a constant state of flux. (A domain name is used to identify and locate computers on the Internet.)
He and other operatives have gone undercover in other countries, with the cooperation of foreign law enforcement, to lure out the suppliers of these illegal medicines and to track down the site operators.
The drugs that these rogue pharmacies sell typically come from Southeast Asia, the Middle East, North Africa and South and Central America. The site operators are in the U.S. and all over the world. FDA coordinates its investigations with law enforcement agencies in many other countries, Burke explains. In some cases, the suspects are turned over to authorities in the country in which they were based; in other cases they are extradited to the United States for prosecution.
FDA is expanding its law enforcement presence overseas as well. In 2014, the first permanent OCI agent overseas will begin an assignment at Europol—the European Union's law enforcement agency—in The Netherlands.
Consumer Advice
Websites that illegally sell prescription drugs also potentially present non-health related risks, such as identity theft, computer viruses or credit card fraud. FDA asks consumers to report suspected criminal activity at www.fda.gov/oci.
FDA provides information on how consumers can identify a fake online pharmacy and offers advice on how to find a safe online pharmacy at BeSafeRx: Know Your Online Pharmacy.
"Consumers should also beware of offers that some sites make to attract customers, such as offering a commission or a referral bonus for bringing in new customers. They might offer 'bonus pills' with a purchase," says Burke. "They're unscrupulous."

Saturday, August 31, 2013

Wellness Pharmacy Recalls 6 more Drugs

 Wellness Pharmacy, Inc. is voluntarily recalling the following medications:
Product Name
Lot#
Expiry
Dexpanthenol 250mg/ml130605@5212/2/2013
Magnesium sulfate 50%130613@3812/10/2013
Methylcobalamin 1mg/ml130612@4912/9/2013
10/19/2013
Sodium Phenylbutyrate 200mg/ml SDV PF130621@2810/19/2013
R.L. Glutathione 100mg/ml SUV PF130710@271/6/2014
Ascorbic acid (cassava) 500mg/ml PF SUV130711@131/7/2014

This recall was initiated after Wellness Pharmacy was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used by Front Range Labs to assess sterility and other qualities (e.g., strength and stability) may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on these lots. FDA has concerns that test results obtained from Front Range Labs may not be reliable.

If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening. To date Wellness Pharmacy has not received any reports of adverse events related to this recall.

Recalled medications were distributed to individual patients and to physician offices nationwide. These liquid medications are in either clear or amber sterile vials ranging in size from 1ml to 50ml. The medications can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size.

Wellness Pharmacy is notifying its customers by telephone and regular mail of this recall. Patients and physicians should immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy.

To return medication or request assistance related to this recall, patients and physicians should contact Wellness Pharmacy at 205-879-6551 or 800-227-2627, Monday through Friday, between 9 a.m. and 4 p.m. CDT.

Patients should contact their physician or health care provider if they have experienced any problems that may be related to taking these medications.

Adverse reactions experienced with the use of these medications may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm  
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178 

Wednesday, August 28, 2013

Compounding Pharmacy Center Recalling Two Drugs


August 23, 2013, Irvine, Ca. Park Pharmacy & Compounding Center is voluntarily recalling two lots of products Methylcobalamin 5 mg/ml 30 ml Amber Vials Lot #06132013@1 Exp: 12/10/2013 and Multitrace-5 Concentrate 10 ml Amber Vials Lot #05212013@20 Exp: 11/17/2013 for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.

The prescription preparations were sold during June and July of 2013, in the following states: California, Florida, New Mexico and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).
To date there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. We are voluntarily recalling the products as a precautionary measure for the safety of our patients.
Park Pharmacy & Compounding Center is notifying its customers by phone and mail and is arranging for return of all recalled product lots. Customers that have product which is being recalled should stop using it and contact Park Compounding to arrange for return of unused product.
Customers with questions regarding this recall can contact Park Pharmacy & Compounding Center at 949-551-7195 or at info@parkrx.com. Monday through Friday, 9 am to 5 pm PST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these preparations.
Adverse reactions experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

It is good to see that the FDA is keeping a closer watch in compounding pharmacys.


                         Methylcobalamin vial label