Wednesday, August 28, 2013

Question of the Day August 28, 2013 In light of the issues at Front Range Laboratories Inc. and the estimate that it tested compounds for 100 compounding pharmacies in 32 states will Congress act quickly in September to help give the FDA the much needed resources to get this enormous problem with compounding preparations under control?

As we are seeing there are issues on the front end of compounding with the bulk powders, issues with the actual compounding (sterility and potency) and now with the testing laboratories with  blurred or no lines as to who oversees what it.  Compounding pharmacists who feared what federal regulation would do to their business now have far greater concerns-lack of trust by the public, liability issues, etc. with potential federal regulation being the least of the worries and potentially a blessing to the good compounders doing it right.  With these overwhelming and out-of-control issues in the compounding world, Congress would be doing a grave injustice to the American people if it does not pass some form of federal legislation. 

We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds

on August 27, 2013
The expected backlash to attempts by the FDA to crackdown on compounding pharmacies has begun, threatening public safety.
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.

continue to read here

Safety Alerts for Human Medical Products Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination

Safety Alerts for Human Medical Products Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination

Tuesday, August 27, 2013

URGENT AND IMPORTANT!! Sterility Concerns at Three More Pharmacies Prompt Recalls

Three more compounding pharmacies are recalling products due to concerns that some of their products may not be sterile, the US Food and Drug Administration (FDA) has announced.
Front Range Laboratories, in Loveland, Colorado, are at the center of 2 of the recalls.
On Monday, JCB Laboratories recalled 6 lots of sterile drug products to the user level because of concerns about sterility assurance following a recent FDA inspection of Front Range Labs, one of the contract testing labs used by JCB. The products, lot numbers and expiration dates are:
ProductLot # (expiration date)
Sodium thiosulfate 25% (250 mg/mL)
130701@9 (12/28/13)
130709@6 (1/5/14)
130717@2 (1/13/14)
Sodium citrate 4% solution injection, 30 mL multiple-dose vial130710@4 (1/6/14)
Sodium citrate 4% w/gentamicin, 320 mcg/mL multiple-dose vial130620@2 (12/17/13)
Acetylcysteine, 20% solution for inhalation, 4 mL single-dose vials130627@5 (8/26/13)
 
The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8 through August 20, 2013.
After an inspection of Front Range Labs, the FDA issued an alert to pharmacies on August 21 stating that "the methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."
"Out of an abundance of caution, JCB has discontinued its relationship with Front Range and is now testing products at a different laboratory," the company said.
JCB has not received any reports of adverse events related to this recall to date, the company said. However, if there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
JCB is notifying its customers by telephone, email, fax, and mail. To return product or request assistance related to this recall, users should contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8 AM. and 5 PM CDT.
Similar Concerns at Second Pharmacy
Concerns at Front Range Labs has also prompted Wellness Pharmacy, Inc, in Birmingham, Alabama, to recall 6 products. They are:
ProductLot #Expiration date
dexpanthenol 250 mg/mL130605@5212/2/2013
magnesium sulfate 50%130613@3812/10/2013
methylcobalamin 1 mg/mL130612@49
12/9/2013
10/19/2013
sodium phenylbutyrate 200 mg/mL SDV PF130621@2810/19/2013
R.L. glutathione 100 mg/mL SUV PF130710@271/6/2014
ascorbic acid (cassava) 500 mg/mL PF SUV130711@131/7/2014
 
The 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 1 mL to 50 mL, the company said. 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 andphysicians should immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy," the company advises.
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 AM and 4 PM CDT.
Testing Issues at Third Pharmacy
On Friday, Park Pharmacy & Compounding, in Irvine, California voluntarily recalled to the consumer level 2 lots of methylcobalamin 5 mg/mL 30 mL amber vials with lot # 06132013@1 and an expiration date of 12/10/2013.
The company also recalled multitrace-5 concentrate 10 mL amber vials for injection with lot # 05212013@20 and an expiration date of 11/17/2013, to the consumer level.
This recall was also prompted by a recent FDA inspection of the laboratory used by this pharmacy, although the laboratory was not named in the company release posted on the FDA Web site.
The prescription preparations were sold during June and July of 2013, in 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. We are voluntarily recalling the products as a precautionary measure for the safety of our patients," the company said.
Park Pharmacy & Compounding is notifying its customers by phone and mail and is arranging for return of all recalled product lots. Customers with product being recalled should stop using it and contact Park Pharmacy & Compounding to arrange for return of the unused product. Customers with questions regarding this recall can contact Park Pharmacy & Compounding at 949-551-7195 Monday through Friday, 9 AM to 5 PM PST, or at info@parkrx.com.

Thomas J. Henry Injury Attorneys Investigating 10 deaths linked to IV drugs from Specialty Compounding, LLC   National Law Firm Now Representing 59 Individuals Potentially Affected by Tainted IV Meds

CORPUS CHRISTI, TX (August 27, 2013)Thomas J. Henry Injury Attorneys is currently representing 59 individuals and investigating 10 deaths in individuals who may have been exposed to tainted IV drugs at Corpus Christi Medical Center Bay Area and Corpus Christi Medical Center Doctors Regional hospitals.

The calcium gluconate IV medications, which are believed to be tainted by rhodococcus equi bacterium, were recalled by Specialty Compounding, LLC on August 9, 2013.

As more and more victims come forward, the firm continues to uncover new information regarding the infections

“We have seen a tremendous number of people come forward, concerned about their safety and the safety of their loved ones,” lead attorney Thomas J. Henry said. “We are working diligently to get to the truth of how institutional errors resulted in so many patients being affected.”

—10 Deaths Linked to Calcium Gluconate—


The firm is currently investigating 10 deaths in hospital patients who may have received calcium gluconate IV injections manufactured by Specialty Compounding, LLC. The individuals were patients of Corpus Christi Medical Center Bay Area or Corpus Christi Medical Center Doctors Regional hospitals.

While initial investigations into the IV infections centered primarily on Specialty Compounding, LLC, the rise in number of severe injury and death claims has required the firm to broaden its focus to encompass any and all entities with a duty to protect patients from defective or tainted drugs.


“These deaths put a greater focus on the hospitals. What the hospitals could or should have done to protect patients and what they should have known about the products they were putting in their patients’ bodies. It also raises questions regarding the timeline of events…specifically when the hospitals suspected a problem and how long it took them to inform patients and the public,” Henry said.

According to a letter sent to several firm clients by Corpus Christi Medical Center, patients at risk for infection from calcium gluconate (produced by Specialty Compounding, LLC) were notified in writing by the hospital onAugust 15, 2013. This was 6 days after Specialty Compounding, LLC issued a nationwide recall on the medication, citing infections at Corpus Christi Medical Center hospitals


“Six days is too long to wait when patients are at risk for serious injury and death,” Henry stated.

—Corpus Christi Medical Center Sends out Letter to Patients—

Click Here to view CCMC Letter to Patients

The letter sent to several of the firm’s clients on August 15, 2013 alerts patients to the possibility that they received an IV solution that has been linked to infections.



The letter warns about unexplained fever and the possibility of infection but makes no mention of Specialty Compounding, LLC, calcium gluconate, the nationwide drug recall, or rhodococcus equi. It also fails to mention the 15 infections reported to the FDA, the severity of reported injuries, or risk of death.



“The ambiguous language leaves many questions unanswered- namely, when the hospital knew about possible infections and how long it took them to relay that information to potentially affected patients,” Henry said. “The answers to these questions and the overall resolution of the case will be important not only to our current clients, but to the safety of future patients as well.”



The letter reads:



“We are writing to let you know that during your recent stay at Corpus Christi Medical Center you may have received an IV solution purchased from a regional pharmacy that isbelieved to have caused some patients to get an infection…”

By this time, both Specialty Compounding, LLC and the U.S. Food and Drug Administration had announced nationwide recalls on the IV solution, citing 15 infections. In their own recall, Specialty Compounding stated “The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area.”

The letter goes on to read:



“…as soon as we became awareof this issue we immediately stopped using this product and all products purchased from this company…”



This raises several questions, including:



Ø  When exactly did Corpus Christi Medical Center become “aware” of the “issue?”

Ø  Was it on August 9, 2013, when Specialty Compounding recalled the medication citing infections at Corpus Christi Medical Center hospitals?

Ø  Or was it prior to that, when a lab technician at Corpus Christi Medical Center discovered rhodococcus equi in patients who had been treated with the IV meds?



What is clear is that Corpus Christi Medical Center did not send out letters informing patients until August 15, 2013.



The letter further states:



“…effects, if any, from this IV solution are usually immediate, so it is unlikely you will have any symptoms, such as unexplained fever, if it has not happened by this time.”



Many families affected simply find themselves asking more questions.



—Incident Spurs Nationwide Recall on IV Drugs—



The injuries reported in Corpus Christi, Texas led to a nationwide recall on all unexpired sterile products from Specialty Compounding, LLC, a compounding pharmacy located in Cedar Park, Texas.



According to the Voluntary Recall Notice issued by Specialty Compounding, LLC:



“Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to individuals located nationwide with the exception of North Carolina.”



—Firm Files TRO, Obtains Temporary Injunction—



Click Here to view the latest Temporary Restraining Order filed by Thomas J. Henry Injury Attorneys



The firm filed two Temporary Restraining Orders (TROs) against Specialty Compounding, LLC in order to preserve evidence related to the cases. The first TRO was filed on August 14, 2013 (Cause No. 2013-CCV-61504-2, Nueces County Court at Law No. 2). A second TRO (Cause No. 2013-CCV-61520-2, Nueces County Court at Law No. 2) was filed August 16, 2013 to include several more individuals potentially affected by the recalled IV drugs from Specialty Compounding, LLC.



Click Here to view the Temporary Injunction Order



On August 26, 2013, Thomas J. Henry Injury Attorneys obtained a Temporary Injunction Order, requiring Specialty Compounding, LLC to preserve evidence relating to the cases until trial, which is anticipated to occur in early 2014.





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