Chin Gets 8 Year Sentence in NECC Case

By Walter F. Roche Jr.

Boston, Mass. --Stating that the law did not allow him to set a stiffer sentence based on the testimony of victims, a federal judge has given a former pharmacist an eight-year prison sentence for his role in a deadly fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns imposed the sentence today on 49-year-old Glenn A. Chin, who was a supervising pharmacist at the now defunct New England Compounding Center, the company that shipped fungus laden steroids to dozens of health facilities across the country in 2012.
The resulting outbreak sickened at least 793 patients, killing 76 of them.
Stearns rejected the recommendation of prosecutors who had asked that Chin get a 35-year prison sentence. Chin's sentence is one year less than the one Stearns imposed on Chin's boss at NECC, Barry J. Cadden. Cadden has already begun serving that nine year sentence at a federal prison in Pennsylvania.
Stearns, who cited the dereliction of government regulators in failing to act against NECC, said that despite the testimony of victims and survivors of victims, he could only consider the health care providers who bought NECC's products as victims.
"The enhancements do not apply," Stearns said. ""It's not that a judge couldn't do it. I've never done it before and I'm not going to do it in this case."
Prior to his ruling victims and survivors, including Colette Rybinski of Tennessee testified about the suffering and deaths that resulted when patients were injected with steroids laden with deadly fungi.
Rybinski described the suffering of her late husband Tom, who was the first victim of the outbreak to be identified following his injection with contaminated methylprednisolone acetate at a Nashville clinic.
She asked Stearns to impose "the maximum sentence possible" to keep the tragedy "from ever happening again."
Just prior to the sentencing Chin told the judge he was "truly sorry" and, repeatedly broke down in tears, saying he has been praying every day for the living victims to fully recover and "stay healthy."
Stearns later said he was convinced Chin was "truly remorseful."
Chin was convicted in October on racketeering, conspiracy, mail fraud charges and violations of the Food Drug and Cosmetic Act. The jury failed to convict him on 25 counts of second degree murder. Cadden was cleared on those same murder charges, but convicted on parallel racketeering and mail fraud charges.
In the hearing today before imposing the sentence Assistant U.S. Attorney Amanda Strachan said the 35-year sentence was necessary to send a message to drug compounders across the country. She said lobbyists for the industry were lobbying for easements in regulation "despite the outbreak."
Chin, she said, in his role as a supervising pharmacist, ordered his subordinates to hide evidence of violations even as federal regulators poured into the Framingham, Mass. facility following the outbreak.
She said he ordered workers to put trash cans over cracks in the floor of the so-called clean room where sterile drugs were being prepared and lied to investigators from the U.S. Food and Drug Administration "when people were dying. That's how we know his intent."
She said Chin also never disclosed to federal investigators that he had $636,000 in a retirement account. Instead, she said, he used the money to buy a new sport utility vehicle for $47,500.
Chin's attorney Stephen Weymouth urged Stearns to follow the same logic he had used in setting Cadden's sentence last year.
Acknowledging that his client did "not step up and he did not quit," Weymouth said Chin's ethnic background made it impossible for him to stand up to Cadden and question unsanitary conditions at NECC.
"I don't expect anyone to feel sorry for Glenn Chin." Weymouth concluded. "There is no way of explaining away what happened."
Weymouth had recommended that Stearns impose a 37 month prison sentence.
He also cited his client's longtime involvement in a youth sports group and his record as a "a good pharmacist" before joining NECC.
A key element in setting the sentence was the economic loss that could be attributed to the criminal activities of Chin and Cadden. While prosecutors said the loss should total $132.6 million, Stearns ruled that the loss be limited to $1.4 million, the value of the drugs that he said prosecutors actually proved were sent out fraudulently.
Although Assistant U.S. Attorney George Varghese told Stearns he would appeal the sentencing decision, U.S. Attorney Andrew Lelling and other federal officials issued a statement praising the overall outcome.
Lelling said that "again and again  he (Chin) acted with complete disregard for the health and safety of patients."
Prosecutors had argued all of NECC's drugs from its inception were produced and shipped as part of a fraudulent enterprise. The $132.6 valuation could have brought Chin a life sentence.
Other victims to testify included Will Mazure, a Michigan resident, who said he still suffers the after effects of the disease and the painful antifungal medications. He said a prior spinal fusion had to be dismantled.
"It was horrible," Mazure said as he described his still ongoing symptoms including memory impairment.
"I can't stay focused," he told the judge.
After the court session he told reporters that as a result of the judge's decision no one is going to be held responsible for the deaths.
Mary Beth Krakowski described how her aunt, Alice Machowiak, was forced to use a walker in the days leading to her death. She said her aunt would wait until after dark to retrieve her mail so that neighbors wouldn't see her.
She said Chin had a chance to be the hero and blow the whistle on Cadden and NECC.
"He could have been the unsung hero," she said.
Kathy and Dan Maccoux described how their "vibrant and athletic" daughter Tracy, one of the youngest victims, had her life completely derailed after being stricken with  meningitis following her injections with drugs prepared by Chin.
"All of our lives became a living hell," Kathy Maccoux said.

Contact: wfrochejr999@gmail.com

Chin Seeks 37 Month Sentence in NECC Case

By Watlter F. Roche Jr.

Glenn Chin, the 49-year-old former pharmacist convicted of racketeering and mail fraud for his role in the 2012 fungal meningitis outbreak is asking the judge presiding over his case to limit his sentence to 37 months.
In a 25-page filing today Chin's lawyer argued that the only victims of the outbreak were the physicians and health care providers who purchased drugs from Chin's company not the nearly 800 patients who were sickened or the 76 who died after injection with drugs Chin prepared.
"While the patients have endured terrible suffering they do not meet the definition of vulnerable victims," the sentencing memorandum states.
The recommendation is in sharp contrast to the one submitted late last week by federal prosecutors who asked U.S. District Judge Richard G. Stearns to send Chin to jail for 35 years.
The recommendations come before a hearing scheduled for Wednesday in U.S. District Court in Boston, Mass.
Chin argued that several so-called enhancements sought by prosecutors to lengthen his sentence, such as the large number of victims and the fact that Chin, a supervising pharmacist at NECC held a position of trust, did not apply to the facts of his case.
Citing the statements of federal prosecutors themselves, Chin stated that co-defendant Barry J. Cadden ran NECC, making all decisions and personally directing all of Chin's activities.
Chin's motion also disputes the of value losses federal prosecutors claim resulted from his criminal activity. Some of those drugs were not defective even though they were prepared by an unlicensed technician, the filing notes.
And literally for years, the filing states, NECC shipped drugs without any complaints or problems.
"Mr. Chin should not be sentenced based on drugs that were not proven deficient at trial," the brief states.
Noting that Chin was a salaried employee who did not share in profits as Cadden did, the motions concludes that imposing the 35 year sentence would result "in an utter travesty of justice."
Cadden already is serving a nine year prison sentence based on his conviction on similar charges. Proecutors had sought a 35 year sentence in his case also.
Both Cadden and Chin were cleared of second degree murder charges in the deaths of 25 patients.
Contact: wfrochejr999@gmail.com

Chin Seeks Delay on Restitution, Forfeiture

By Walter F. Roche Jr.

The attorney for a pharmacist convicted on racketeering and mail fraud charges is asking a federal judge to delay a scheduled hearing on his client's restitution and forfeiture liability.
Stephen Weymouth, the lawyer for Glenn Chin, submitted the request today to U.S. District Court Judge Richard G. Stearns.
A Wednesday hearing is scheduled for Chin's sentencing. The restitution and forfeiture issues were scheduled to occur at the same hearing in U.S. District Court in Boston, Mass.Federal prosecutors have asked for a $611,744 restitution order against Chin.
Chin was one of 14 indicted in 2014 following a two year probe of a deadly fungal meningitis outbreak.
Late last week federal prosecutors asked Stearns to impose a 35-year prison sentence on the Canton, Mass. resident.
Weymouth said in his delay request that he needed further time to review victim impact statements.
Nearly 800 patients were sickened in the outbreak caused by fungus ridden steroids shipped from the now defunct New England Compounding Center, where Chinn was employed as a supervisor.
Co-defendant Barry J. Cadden, the one time president of NECC, already is serving a nine-year prison sentence following his conviction on related charges. Stearns already has imposed a $7.5 million forfeiture order against Cadden.
Contact: wfrochejr999@gmail.com

Goverment Seeks 35 Year Chin Sentence

By Walter F. Roche Jr.

Stating that the pain he caused has "no foreseeable end," federal prosecutors are asking a federal judge to impose a 35-year prison sentence on a pharmacist who played a key role in a deadly fungal meningitis outbreak.
In a 51-page filing in U.S. District Court in Boston, Mass., the prosecutors said actions by Glenn A. Chin caused "widespread harm and unimaginable suffering."
The filing comes just days before Chin's sentencing following his conviction last year on charges of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act.
Included in the filing were details of the suffering some of the victims have endured.
If Chin were to get the 35 year sentence it would be nearly four times the sentence U.S. District Judge Richard G. Stearns imposed on codefendant Barry J. Cadden. Cadden who was convicted on similar charges, already has begun serving the nine year sentence Stearns imposed. Prosecutors had also asked for Cadden to serve a 35-year sentence.
In fact a substantial portion of the government's sentencing memorandum criticizes Stearns decision in the Cadden case. Stearn will also decide Chin's sentence on Wednesday.
Chin and Cadden were  among the 14 indicted in December 2014 following a federal probe of the 2012 fungal meningitis outbreak, which took the lives of some 76 patients. The outbreak was caused by contaminated drugs shipped by the New England Compounding Center, the now defunct Framingham, Mass. firm where Cadden and Chin worked.
Cadden was president and part owner of NECC and Chin ran the clean room where the contaminated drugs were produced.
In a footnote in the filing, the prosecutors disclosed for the first time that NECC's drugs sickened some 793 patients, some 35 more than previously reported.
"The court was wrong in concluding that the patients receiving injections of NECC's contaminated drugs are not victims of the rackteering and mail fraud," the filing states, adding that the patients were "clearly victims."
"They trusted that the drugs would relieve and not cause pain," the filing by Assistant U.S. Attorneys Amanda Strachan and George Varghese states.
The prosecutors also argued that Stearns' decision in the Cadden case grossly understated the loss caused by Cadden and Chin. Citing decisions in other cases, they said the loss caused by Cadden and Chin should include all the money paid to NECC from 2006 to 2012, or $132.8 million not just $1.4 million.
"No one would have bought any of NECC's drugs had they known the truth about NECC's operations. NECC's drugs were worthless," the filing states. "NECC's entire manufacturing operation was a fraud."
The filing recounts the trial testimony last Fall in which former NECC's employees described insanitary conditions at NECC, the lack of testing of its drugs, the use of outdated and expired ingredients and the shipping of drugs before tests could even be completed.
Citing the the "seriousness of Chin's crimes," the prosecutors said, "a lengthy period of incarceration is warranted here."
"The suffering that resulted when 14 strains of fungi swimming in Chin's methylprednisolone acetate made their way into patients is immeasurable," the memo states.
The prosecutors specifically cited the impact statements submitted by victims from Michigan, Tennessee and Indiana. Joan Peay, a Nashville, Tenn. victim, said she still suffers from the after effects of two bouts of fungal meningitis and the debilitating anti-fungal treatments.
"The worst is the damage to comprehension," Peay wrote. "It doesn't sound like much but it has been terrible."
Contact: wfrochejr999@gmail.com

Final NECC Trial Re-Scheduled

By Walter F. Roche Jr.

Just a day after setting a March date for the final trial stemming from a deadly meningitis outbreak, a federal judge has issued an order putting the trial of nine defendants off for seven months.
Citing an irresolvable conflict, U.S. District Judge Richard G. Stearns revoked his Wednesday order setting a March trial date and issued a new one setting Oct. 2 trial date for the nine remaining defendants stemming from a two-year probe of the 2012 fungal meningitis outbreak.
In the brief order Stearns said he had learned his Wednesday order created a conflict for at least one attorney involved in the case and that other defense lawyers needed additional trial preparation time.
Noting that federal prosecutors were unwilling to split off any of the cases, Stearns said that one attorney was already scheduled for a lengthy trial and two others had other conflicts.
Stearns said he was also sensitive to the fact that two of the defendants, Kathy Chin and Michelle Thomas, had just been brought back into the case by an appeals court ruling. His ruling dismissing charges against the two was overruled after 14 months.
He said attorneys for the two now needed further time to review transcripts, review evidence  and prepare a defense.
The seven others facing trial include Gene Svirsky, Christopher Leary, Joseph Evanosky, Scott Connolly, Sharon Carter, Alla Stepanets and Gregory Conigliaro.
All were connected to the New England Compounding Center, the company blamed for the 2012 outbreak which took the lives of at least 76 patients across the country.
Contact: wfrochejr999@gmail.com

Judge Sets Final NECC Trial Date

By  Walter F. Roche Jr.

A federal judge has set a March trial date for the nine remaining defendants in a case triggered by a deadly fungal meningitis outbreak caused by a rogue Massachusetts drug compounding firm.
U.S. District Judge Richard G. Stearns today set March 16 as the date the trial will begin, with opening arguments scheduled for March 20.
The order comes just days before one of the two main defendants in the case is scheduled to be sentenced following his conviction on racketeering and mail fraud charges. Glenn Chin, who was a supervisory pharmacist at the New England Compounding Center, will appear before Stearns on Tuesday.
In a series of orders issued today Stearns told attorneys for the nine remaining defendants to be prepared to make opening arguments on March 20. He also set deadlines for both sides to submit lists of proposed witnesses and other data by March 8.
He set Feb. 15 as the date for a final pre-trial conference.
The nine were among 14 persons connected to NECC to be indicted in late 2014 following a two year criminal probe of the 2012 fungal meningitis outbreak. Caused by fungus laden spinal steroids, the outbreak sickened some 778 patients across the country, killing at least 76 of them.
Chin and Barry J. Cadden, the two primary defendants, already have been convicted on racketeering and mail fraud charges, but two separate juries concluded that there was not sufficient evidence to convict them on 25 counts of second degree murder.
Cadden already has begun serving a nine-year sentence at a federal prison in western Pennsylvania.
Those now scheduled for trial in March are Gregory Conigliaro, Gene Svirsky, Christopher M. Leary, Joseph Evanosky, Scott Connolly, Alla Stepanets, Kathy Chin, Michelle Thomas and Sharon Carter. Conigliaro was an NECC vice president and part owner. The others held various positions at NECC.
Two of the original 14 defendants, Carla and Douglas Conigliaro, entered guilty pleas to vastly reduced charges. They were fined and placed on probation with no prison sentences.
Robert Ronzio, an NECC salesman, has entered a guilty plea and is awaiting sentencing. He already has testified as a witness for the prosecution.
Contact: wfrochejr999@gmail.com

$611,774 Forfeiture Order Sought on Chin.

By Walter F. Roche Jr.

Federal prosecutors are asking a judge to issue a $611,774 forfeiture order against, Glenn Chin, the pharmacist convicted of racketeering, conspiracy and mail fraud for his role in deadly fungal meningitis outbreak.
In a nine-page motion filed this week in U.S. District Court in Boston, Mass. the prosecutors said the $611,774 represented the traceable wages paid to Chin from 2006 to October of 2012, when the New England Compounding Center, Chin's employer, was forced to shutdown.
According to an affidavit filed along with the motion the figure does not include any income for 2008 and 2009, because records for those years could not be located.
Chin was convicted in October of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act. He is scheduled to be sentenced Jan. 31.
Chin was a supervising pharmacist at NECC, the Framingham, Mass. company blamed for the 2012 fungal meningitis outbreak. He was the supervisor in the clean room where steroids laden with a deadly fungus were produced and shipped all over the country.
Chin's earnings were not made public during his 27-day trial. In contrast earnings and profits netted by co-defendant Barry J. Cadden were detailed during his trial which preceded Chin's. Cadden, the president and part owner of NECC has been hit with a $7.5 million forfeiture order and already is serving an 11 year prison sentence following his March conviction on parallel charges.
A government  witness testified at Cadden's trial that he and his wife earned $18 million in profits between 1998 and 2012.
Both Chin and Cadden were cleared by separate juries of 25 counts of second degree murder.
According to the motion and affidavit filed this week, federal investigators were unable to locate the $611,774 because Chin apparently used the wages to pay ongoing living expenses.
Chin, Cadden and a dozen others were indicted in December of 2014 following a two year probe of the fungal meningitis outbreak which sickened 778 patients, killing 76 of them.
Contact: wfrochejr999@gmail.com

Nine Still Face Trial in NECC Case

By Walter F. Roche Jr.

Though it has been more than five years since a deadly fungal meningitis sickened 778 patients across the country nine of the 14  charged criminally for their roles in the public health disaster have yet to go to trial.
That number jumped from seven to nine just last week when a federal appeals court reinstated the charges against some of the original 14. The First Circuit Court of Appeals overturned a ruling by U.S. District Judge Richard G. Stearns who had dismissed charges against two former employees of the New England Compounding Center, the company blamed for the outbreak.
In a 19-page decision the three judge panel reinstated the charges against two licensed pharmacists, Kathy S. Chin and Michelle L. Thomas. A third defendant, Alla Stepanets, also had charges against her restored but she was already facing a trial on a related conspiracy charge.
The other defendants awaiting trial held various positions at NECC ranging from Gregory Conigliaro, an officer and part owner, to Gene Svirskiy, a supervisory pharmacist in charge of one of the so-called clean rooms where sterile drugs were prepared.
A trial date has not yet set.
Others awaiting trial are Christopher M. Leary, Joseph Evanosky, Scott Connolly and Sharon Carter. The charges range from racketeering to mail fraud and conspiracy.
Two of the original 14, Carla and Douglas Conigliaro, entered guilty pleas to vastly reduced charges. They were fined and placed on probation with no prison sentences.
Robert Ronzio, an NECC salesman, has entered a guilty plea and is awaiting sentencing.
Two of the original defendants, Barry J. Cadden and Glenn Chin already have been tried and were convicted of some, but not all the charges. Separate juries concluded prosecutors failed to prove 25 counts of second degree murder.
Cadden already is serving a nine year prison sentence. Chin is scheduled for sentencing on Jan. 31.
Contact: wfrochejr999@gmail.com

Charges Reinstated in NECC Case

By Walter F. Roche Jr.

A federal appeals court has reversed the decision of a district court justice who had dismissed charges against three defendants indicted in the aftermath of the deadly 2012 fungal meningitis outbreak.
In a 19-page decision issued in Boston, Mass. the First Circuit Court of Appeals said the three must face trial on charges that they participated in the distribution of mis-branded drugs.
The decision means two of the three, Kathy Chin and Michele Thomas will face trial along with several other remaining defendants.
The third defendant, Alla Stepanets, had a remaining conspiracy charge that was not dismissed by U.S. District Judge Richard G. Stearns.
Stearns had concluded that the work the three licensed pharmacists performed at the New England Compounding Center was merely clerical because they were matching up a list of drugs with lists of patients. He concluded their tasks did not rise to the level of dispensing.
The appeals court, however, concluded that the three were not merely present, but were "culpably present" when they matched up drugs with what were obviously fake patient names. The names included Wonder Woman, Fat Albert, L.L. Bean and Coco Puff.
The court found the 131 count indictment "easily passes muster" in providing sufficient notice to the three defendants.
"So the indictment gives the defendants enough info to prepare a defense and to invoke double jeopardy protections to forestall a later trial on the same charges," the ruling states.
The three were among 14 indicted in late 2014 by a federal grand jury investigating the 2012 fungal meningitis outbreak caused by fungus laden drugs shipped to health facilities across the country.
Some 778 patients were sickened and 76 of them died.
Two of the defendants already have gone to trial and were found guilty of some, but not all of the charges.
Barry Cadden, a part owner and president of NECC, already is serving a nine-year prison sentence while Glenn Chin faces sentencing on Jan. 31 following his conviction on racketeering and mail fraud charges.
Glenn Chin, is the spouse of Kathy Chin.
Several other defendants have entered guilty pleas.

Massive Compounded Drug Recall Ongoing

Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance

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For Immediate Release

January 11, 2018

Contact

Consumers

Leigh Briscoe-Dwyer, Vice President Clinical Affairs
  lbriscoe@pharmedium.com
 (847) 457-2801

Media

Andrew Harrison, Vice President of Legal and Compliance
  aharrison@pharmedium.com
 (847) 457-2271
Sanjeev Bahl, Vice President Quality
  sbahl@pharmedium.com
 (847) 457-2256

Announcement

PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.  To date, PharMEDium has not received any reports of adverse events related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.
The recall is being expanded because PharMEDium conducted  an extensive review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding microbial program controls for the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results following the most recent inspection.  The original recall included a total of 55 lots of different products impacting 25,327 units.  The expanded recall includes all lots within expiry compounded at our Memphis, TN facility. Finished product release testing for both sterility and endotoxin were acceptable for all lots. Although there were no defects identified in these products, as a conservative measure, this recall is being expanded.
The products can be identified by referring to the sample labels provided below.  These products were distributed nationwide in the USA to hospitals/clinics.  A complete list of all recalled products can be found on pharmedium.com.
PharMEDium Services is notifying customers of the voluntary recall by phone and email. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. Customers with any of the affected medications can also reference PharMEDium Services website (pharmedium.com) for more information on the specific lot numbers affected and contact information.
Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at 1-800-523-7748, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at recall17023@pharmedium.com.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.
Adverse reactions or quality problems 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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Initial Press Release

###

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Victims Blocked From Needed Care

By Walter F. Roche Jr.

Five years later Vicki Scott, a Virginia victim of the 2012 fungal meningitis outbreak, is still suffering after effects of the original disease and the powerful anti-fungal drugs used to treat it, but she, like many other outbreak victims, is finding it increasingly difficult to get medical care.
In recent interviews Scott, a Roanoke resident, cited repeated instances of physicians and other health care providers either refusing to even give her an appointment or cancelling a scheduled visit before she could even get in the door.
She is not alone.
Terri Lewis, a Tennessee resident who has taken on the role of advocate for dozens in similar situations, there are victims from many other states including Indiana and Kentucky where they are having difficulty getting needed follow up care.
"She's been blackballed," Lewis said of Vicki Scott.
Lewis also blames federal agencies for failing to take an active role in helping victims get needed care.
"They clearly didn't do their jobs," she added.
As for the victims, Lewis said many are continuing to experience multiple health problems related both to the original disease - in many cases fungal meningitis - and the lingering health issues caused by Voriconazole, or other antifungal drugs.
The 2012 fungal meningitis outbreak sickened at least 778 patients, killing 76 of them. It was caused by highly contaminated vials of a steroid called methylprednisolone acetate, which was produced as a now defunct Massachusetts drug compounding company. The steroids were injected into the spines and joints of unsuspecting patients in more than 20 states.
Scott says some have even questioned whether she really was a victim, even though her medical records indicate she was being treated for fungal meningitis.
Lewis noted that another roadblock facing victims is the ongoing efforts to reduce or eliminate pain treatment with opiods.
"Many doctors are afraid to prescribe those drugs," Lewis said, adding that federal regulators are "criminalizing pain care. A lot of these patients have no alternatives.
Scott, who describes herself as "very angry and upset," says she really doesn't know where to turn for help.
When she questioned officials at one area health facility about the reason her appointments were cancelled, she said she was told she should never have been given an appointment in the first place.

Drug Recall Due to Sterility Concerns

ompounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance AUDIENCE: Risk Manager, Pharmacy ISSUE: PharMEDium Services is voluntarily recalling certain lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. See the press release for a listing of affected products. BACKGROUND: PharMEDium conducted a retrospective review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding microbial control program during recent inspection to provide verification of acceptable microbiological testing results of the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results. The review indicated that a total of 55 lots of different products impacting 25,327 units had two unsuccessful media fills. The remaining lots were associated with environmental monitoring or personnel monitoring excursions in the ISO 5 space on hood/surface and glove tip. Finished product release testing for both sterility and endotoxin were acceptable. Although there were no defects identified in these products, as a conservative measure, a recall is being initiated. The recalled products were distributed nationwide in the USA to hospitals/clinics. RECOMMENDATION: PharMEDium Services is notifying customers of the voluntary recall by phone. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. Customers with any of the affected medications can also reference PharMEDium Services website for more information on the specific lot numbers affected and contact information: www.pharmedium.com. Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at (847) 457-2220, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at dantonio@pharmedium.com. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch Safety Alert, including a link to the press release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm591048.htm