Author: Phyllis Entis

Fungal Meningitis Outbreak – FDA Inspection Report

Aspergillus fumigatus (courtesy of CDC)

Twenty-five people are dead; 331 are suffering from fungal meningitis; an additional 7 people havedeveloped fungal infections in other joints (knees, elbows, etc). All courtesy of a pharmaceutical compounding facility that is filthier than many dog kennels!

FDA released its Preliminary Inspection Report (Form 483) today, and the observations are nauseating. A small sampling of the specifics include:

1. On 10/02/2012, we observed approximately eighty-three (83) vials out of a bin containing 321 vials of methylprednisolone acetate (preservative free) 80mg/mL from Lot #08102012@51 (shipped to customers between 8/17/12 – 9/25/12 …), a sterile injectable drug, to contain what appeared to be greenish black foreign matter. Seventeen (17) vials from the same bin… were observed to contain … white filamentous material.

The sterility sample taken by the firm … from lot 08102012@51 resulted in a sterile result… However, the FDA analysis of … Lot #08102102@51 collected from the firm, confirmed the presence of viable microbial growth in 50/50 vials tested. One vial examined microscopically showed fungal morphological features.

2. Although the formula worksheets state the raw materials are sterile, the Pharmacy Director stated that the firm uses non sterile active pharmaceutical ingredients (APIs) and raw materials, with the exception of sterile water for injection…The firm provided no documentation or evidence to support that the steam autoclave cycle used to sterilize suspensions formulated using non-sterile API and raw materials is effective.

3. The firm’s environmental monitoring program yielded … (bacteria and mold) within Clean Room 1 and Clean Room 2, used for the production of sterile drug products, between January 2012 and September 2012.

There was no investigation conducted by the firm when levels exceeded their actions limits and there was no identification of the isolates. No documented corrective actions were taken to remove the microbial contamination … from the facility.

And there’s much, much more.

The bottom line is that New England Compounding Center (NECC) used non-sterile materials to manufacture a sterile injectable drug It did so under “Clean Room” conditions that would put a student undergraduate microbiology lab to shame. AND the company neglected to act on lab results that clearly demonstrated that the environment was badly contaminated with bacteria and mold.

Exserohilum rostratum (courtesy of CDC)

As a result of the company’s cavalier attitude, innocent patients in eighteen states have suffered fungal meningitis – in some cases, resulting in stroke – or septic arthritis after receiving injections from one of three lots of methylprednisolone acetate produced by NECC. Although one of the patients was infected with Aspergillus fumigatus and one with Cladosporium, most of the infections were due to a fungus called Exserohilum rostratum – the same mold found by FDA in unopened vials of the “sterile” medication.

NECC “voluntarily” recalled 40 mg/ml and 80 mg/ml strengths of Methylprednisolone Acetate on October 3rd, and extended the recall to all lots of its remaining products the following day. Please consult the Commonwealth of Massachusetts notice for a detailed list of recalled products.

As of October 26th, illnesses have been reported from the following states:

  • Florida: 19 cases (3 deaths)
  • Georgia: 1 case
  • Idaho: 1 case
  • Illinois: 1 case
  • Indiana: 43 cases (3 deaths)
  • Maryland: 19 cases (1 death)
  • Michigan: 82 cases (5 deaths)
  • Minnesota: 9 cases
  • New Hampshire: 11 cases
  • New Jersey: 18 cases
  • New York: 1 case
  • North Carolina: 2 cases (1 death)
  • Ohio: 11 cases
  • Pennsylvania: 1 case
  • South Carolina: 1 case
  • Tennessee: 74 cases (10 deaths)
  • Texas: 1 case
  • Virginia: 43 cases (2 deaths)

Heathcare facilities in 23 states were supplied with the contaminated medication.

California

  • CYPRESS SURGERY CENTER. 559-740-4094; Visalia, CA
  • ENCINO OUTPATIENT SURGICENTER. 818-986-1037; Encino, CA
  • UKIAH VALLEY MEDICAL CENTER. 707-463-7345; Ukiah, CA
  • UNIVERSAL PAIN MANAGEMENT. 661-267-6876 x166; Palmdale, CA

Connecticut

  • INTERVENTIONAL SPINE AND SPORTS MED. 203-598-7246; Middlebury, CT

Florida

  • FLORIDA PAIN CLINIC. 352-237-5906; Ocala, FL
  • INTERVENTIONAL REHABILITATION CENTER. 850-484-8800; Pensacola, FL
  • MARION PAIN MANAGEMENT CENTER. 352-622-1845; Ocala, FL
  • NORTH COUNTY SURGICENTER. 561-626-6446; Palm Beach Gardens, FL
  • ORLANDO CENTER FOR OUTPATIENT SURGERY. 407-426-8331; Orlando, FL
  • PAIN CONSULTANTS OF WEST FLORIDA. 850-494-0000. Pensacola, FL
  • SURGERY CENTER OF OCALA. 352-237-5906; Ocala, FL
  • SURGICAL PARK CENTER. 305-271-9100 x226; Miami, FL

Georgia

  • FORSYTH STREET AMBULATORY SURGURY CENTER. 478-749-1610; Macon, GA

Idaho

  • PAIN SPECIALISTS OF IDAHO. 208-522-7246; Idaho Falls, ID
  • WALTER KNOX MEMORIAL HOSPITAL. 208-365-3561 x3342; Emmett, ID

Illinois

  • APAC CENTERS FOR PAIN MANAGEMENT. 708-483-7007; Westchester, IL
  • APAC CENTERS FOR PAIN MANAGEMENT. 773-935-2760; Chicago, IL
  • THOREK MEMORIAL HOSPITAL. 773-975-6734; Chicago, IL

Indiana

  • AMBULATORY CARE CENTER LLC. 812-475-1800; Evansville, IN
  • FORT WAYNE PHYSICAL MEDICINE. 260-436-9337; Fort Wayne, IN
  • OSMC OUTPATIENT SURGERY CENTER. 574-266-4173; Elkhart IN
  • SOUTH BEND CLINIC. 574-237-9372; South Bend, IN
  • UNION HOSPITAL. 812-238-4964; Terre Haute, IN
  • WELLSPRING . 812-376-0700; Columbus, IN

Maryland

  • BALTIMORE PAIN MANAGEMENT. 410-682-5040; Baltimore, MD
  • BERLIN INTERVENTIONAL PAIN MANAGEMENT.  410-641-3759; Berlin, MD
  • BOX HILL SURGERY CENTER. 410-877-8141; Abingdon, MD
  • GREENSPRING SURGERY CENTER. 410-653-0077; Baltimore, MD
  • HARFORD COUNTY ASC, LLC. 410-538-7000; Edgewood, MD
  • PAIN MEDICINE SPECIALISTS. 410-825-6945; Towson, MD
  • SURGCENTER OF BEL AIR. 410-638-5523; Bel Air, MD

Michigan

  • MICHIGAN NEUROSURGICAL INSTITUTE. 810-606-7112; Grand Blanc, MI
  • MICHIGAN PAIN SPECIALISTS. 734-995-7246; Brighton, MI
  • NEUROMUSCULAR & REHABILITATION. 231-935-0860; Traverse City, MI
  • SOUTHEAST MICHIGAN SURGICAL HOSPITAL. 586-427-1000; Warren, MI

Minnesota

  • MAPS-EDINA MEDICAL PAIN CLINIC. 763-537-6000; Minneapolis, MN
  • MAPS-MEDICAL ADVANCED PAIN. 763-537-6000; Fridley, MN
  • MEDICAL ADVANCED PAIN SPECIALISTS. 763-537-6000 x238; Shakopee, MN
  • MEDICAL ADVANCED PAIN SPECIALISTS. 763-537-6000; Maple Grove, MN
  • MINNESOTA SURGERY CENTER. 763-767-7139; Edina, MN
  • MINNESOTA SURGERY CENTER. 763-537-6000; Maple Grove, MN

North Carolina

  • HIGH POINT SURGERY. 336-878-6048; High Point, NC
  • NORTH CAROLINA ORTHOPAEDIC CLINIC. 919-403-5148; Durham, NC
  • SURGERY CENTER OF WILSON. 252-237-5649; Wilson, NC

New Hampshire

  • DR. O’CONNELL’S PAIN CARE CENTER. 603-335-5070; Merrimack, NH
  • DR. O’CONNELL’S PAIN CARE CENTERS, INC. 603-692-3166; Somersworth, NH

New Jersey

  • CENTRAL JERSEY ORTHOPEDICS SPECIALISTS PC. 908-561-2122; South Plainfield, NJ
  • EDISON SURGICAL CENTER. 732-452-0123; Edison, NJ
  • IF PAIN ASSOCIATES / ISAIAH FLORENCE. 201-287-1100; Teaneck, NJ
  • PREMIER ORTHOPEDICS SURG. ASSOC., LLC. 856-690-1750; Vineland, NJ
  • COMPREHENSIVE PAIN MANAGEMENT. 973-796-5216; Sparta, NJ
  • SOUTH JERSEY HEALTH CARE. 856-363-1558; Elmer, NJ
  • SOUTH JERSEY HEALTHCARE. 856-641-7557; Vineland, NJ

Nevada

  • SAHARA SURGERY CENTER. 702-362-7874; Las Vegas, NV (all vials that were sent to Nevada were recalled prior to use)

New York

  • BUTANI, SUNIL H., PHYSICIAN PC. 516-747-5042; Mineola, NY
  • OBOSA MEDICAL SERVICES. 914-530-2323; Mount Vernon, NY
  • ROCHESTER BRAIN AND SPINE. 585-334-5560; Rochester, NY

Ohio

  • BKC PAIN SPECIALISTS, LLC. 740-387-7246; Marion, OH
  • CINCINNATI PAIN MANAGEMENT. 513-891-0022; Cincinnati, OH
  • MARION PAIN CLINIC. 740-375-0200; Marion, OH
  • ORTHO-SPINE REHABILITATION CENTER, INC. 614-793-8817; Dublin, OH

Pennsylvania

  • ALLEGHENY PAIN MANAGEMENT. 814-940-2000; Altoona, PA
  • SOUTH HILLS PAIN & REHAB ASSOCIATES. 412-469-7722; Jefferson Hills, PA

Rhode Island

  • NEW ENGLAND ANESTHESIOLOGY (NEA). 401-490-7530; Warwick, RI
  • OCEAN STATE PAIN MANAGEMENT. 401-766-7700; Woonsocket, RI
  • OCEAN STATE PAIN MANAGEMENT. 401-884-6070; East Greenwich, RI

South Carolina

  • INTERVENE MD. 843-216-4844; Mount Pleasant, SC

Tennessee

  • PCA PAIN CARE CENTER. 865-835-5196; Oak Ridge, TN
  • SPECIALTY SURGERY CENTER. 931-484-2500 x125; Crossville, TN
  • ST. THOMAS OUTPATIENT NEUROSURGICAL. 615-341-3425; Nashville, TN

Texas

  • DALLAS BACK PAIN MANAGEMENT. 214-445-5077; Dallas, TX
  • HARRIS METHODIST SOUTHLAKE CENTER. 817-748-8778; Southlake, TX

Virginia

  • INSIGHT IMAGING-ROANOKE. 540-581-0882; Roanoke, VA
  • NEW RIVER VALLEY SURGERY CENTER. 540-639-5888; Christiansburg, VA

West Virginia

  • PARS INTERVENTIONAL PAIN. 304-865-7277; Parkersburg, WV

CDC has posted the following advice for patients of these facilities:

Find out if you received a potentially contaminated medication.

If you are concerned about which product was used in your procedure, you should first contact the physician who performed your procedure.

Recalled lots of injectable methylprednisolone acetate received by 23 states

  • The facilities that received one of the three lots of methylprednisolone acetate (a steroid product) recalled by New England Compounding Center (NECC) on September 26, 2012, are actively contacting patients to find out if they are feeling well. This is the medication that has been associated with fungal infections in patients.
  • The list of facilities that received medication from one of these three lots is available at http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html.
  • As of October 20, 97 percent of patients who received medication from one of the three lots have been contacted.

Other NECC products under investigation

  • Out of an abundance of caution, the FDA is advising doctors, to follow-up with patients who received an NECC injectable product shipped after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, and a cardioplegic solution. CDC does not have firm evidence that fungal infections have been caused by exposure to other NECC products.
  • If patients have taken or used medications from NECC, and they are worried that they are sick because of use of one of these products, they should seek medical attention.

If you have received a potentially contaminated medication, seek medical attention if you have symptoms.

You may have very mild symptoms that are only slightly worse than usual. For example, many infected patients who received epidural or paraspinal injections have had slight weakness, slightly worsened back pain, or even a mild headache.

Patients who received injections into a joint have experienced increasing pain and swelling of the joint. Patients with infections have typically developed symptoms within 1-4 weeks after their injection. However, shorter and longer timeframes between injection and onset of symptoms have been reported. Therefore, patients need to closely watch for these symptoms for at least several months following the injection. If you do develop these symptoms, you should see a doctor.

More Than 1,000 Ill in Dutch Salmonella Outbreak

The Dutch National Institute for Public Health and Environment (RIVM) reported today that 1,026 people are now confirmed to have been infected with Salmonella Thompson, in an outbreak of salmonellosis that has been linked to contaminated smoked salmon. This represents an increase of 76 cases in the past week.

RIVM notes that the number of new patients is significantly lower than the week before, suggesting that this major outbreak is finally waning.

According to a report in today’s issue of Eurosurveillance, Dutch authorities first became aware of the outbreak on August 2nd, when RIVM staff noticed an increase in the number of Salmonella Thompson cases. This particular Salmonella normally causes only four illnesses annually in the Netherlands.

The index patient developed symptoms of salmonellosis on June 20th. A few more scattered illnesses occurred over the next several weeks; however, the number of illnesses spiked noticeably only in early August. Nearly two-thirds (63%) of the confirmed outbreak victims were female, and 36% were hospitalized. The median age of case-patients was 44 years (range of 0 – 95 years).

While the official case total stands at 1,076, the true number of cases is undoubtedly far higher. RIVM advises that Salmonella is NOT a notifiable disease in the Netherlands. There is no requirement that doctors, hospitals or laboratories report Salmonella infections to  the authorities.

The outbreak was first linked to consumption of smoked salmon as a result of questionnaires administered to patients and to a cohort of healthy individuals (matched to the victims by age, gender and municipality), either by telephone or in person. The results of the questionnaires pointed to consumption of smoked fish – especially smoked salmon. Victims also were more likely to have consumed raw salads and also identified several supermarkets more often than did the healthy control individuals.

Traceback investigations carried out by the Dutch Food and Consumer Product Safety Authority (nVWA), which focussed on smoked salmon and on the highlighted supermarkets, determined that all of the identified supermarkets purchased at least some of their smoked salmon from the same producer –Foppen Paling en Zalm. Lab tests confirmed the presence of the outbreak strain in four of nine batches of smoked salmon from this producer.

A recall of smoked salmon was announced on the nVWA website on September 28th, and expanded a few days later to include a number of additional items – such as salads – that contained the recalled smoked salmon.

The implicated salmon originated in Norway, according to the Rapid Alert System for Food and Feed (RASFF), and was shipped to a Foppen production plant in Greece for processing before traveling in a northwesterly direction to the Netherlands. The smoked salmon was distributed in Belgium, Canada, Curacao, France, Germany, Luxembourg, Mexico, the Netherlands, Switzerland, the United Kingdom and the USA. Nevertheless, the Netherlands remains the only EU country to have noted an increased incidence of Salmonella Thompson infections.

The US Centers for Disease Control and Prevention (CDC) has been investigating a spike in salmonellosis due to this outbreak strain but, as of a few days ago, has not been able to establish a link between the illnesses and the consumption of smoked salmon – or of any other specific food item. This particular strain of Salmonella Thompson is not uncommon in the United States, making determination of a single outbreak source problematic.

For a complete list of recalled smoked salmon products, please consult my earlier post, “Smoked Salmon and Salmonella Thompson – Update #3.“

Recalls and Alerts: October 25, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

For current information on retail distribution of peanut butter products recalled due to Salmonella Bredeney, please consult the Trader Joe’s/Sunland Peanut Butter Recalls tab.

For current information on retail distribution of beef products containing Canadian beef recalled due to E. coli O157:H7 contamination please consult the Canada/USA Beef Recall tab.

United States

  • Outbreak Alert Update (North Carolina): The Division of Public Health reports that, as of today, state and local health agencies have confirmed 104 cases of E. coli infections in attendees at the Cleveland County Fair. The victims include 63 children and 41 adults; one child has died and thirteen victims have been or are currently hospitalized. Animal exposure is thought to be the source of the infections.

Canada

  • Food Safety Recall: Salamina Inc. recalls Sadis brand Pepperoni – 2″ Sliced (20kg; Code #275283), due to Listeria contamination. The recalled product was distributed to hotel, restaurant and institutional customers in Quebec.
  • Food Safety Recall: BV Fisheries recalls BV Fisheries brand Hot Smoked Salmon (Variable size; no codes), due to potential contamination with Clostridium botulinum. The recalled product was sold in retail stores in Newfoundland and Labrador.
  • Food Safety Recall: Outlandish Shellfish recalls Aquacultured Gallomussel Outlandish (10 lb; Lot S245; Harvest date 2012OC15; Subarea 13-12), due to the presence of marine biotoxin. The recalled product was distributed to hotel, restaurant and institutional customers in British Columbia and Ontario.
  • Food Safety Recall: Mills Sea Food Ltd. recalls Mills Sea Food Ltd. Soft Shell Clams (4 lb; Code Oct. 17, 2012), due to the presence of marine biotoxin. The recalled product was sold to retail customers in New Brunswick.
  • Food Safety Recall: Listiguj Commercial Fisheries recalls Live Blue Mussels (25 lb; No codes) due to the presence of marine biotoxin. The recalled product was sold to retail customers in Quebec.
  • Natural Health Product Safety Recall: Wing Quon Enterprises Ltd. recalls Pollen Allergy, now sold as Tongqiao Biyan Pian after testing by Health Canada identifies the presence of arsenic in excess of allowable limits, in addition to low levels of undeclared chlorpheniramine (an antihistamine) and acetaminophen. The recalled product was distributed to retailers in Alberta, British Columbia, Manitoba, Ontario, Quebec, Saskatchewan and the Yukon.

Europe

  • Food Safety Recall (Finland): Oy Hartwall Ab recalls FENIX Weight Control Beverage – Pineapple (0.5L bottles; best before 301112, item L2215 X9086, best before 160113, X9908 and L2262 installment of the best-before 160113, item L2262 X9916), because the product contains chromium, a supplement that is banned in the EU.
  • Food Safety Recall (Greece): Uncle John Ltd. recalls Choco The Monster Croissant with hazelnut praline filling (Expiry 11/16/12), due to mold growth.
  • Vaccine Safety Recall/Alert (Several EU countries): Germany’s Paul Ehrlich institute has cancelled the approval of some batches of Novartis flu vaccine after the company reported the appearance of small particles in the manufacturing process, according to Associated Press. Italy banned the sale of four Novartis flu drugs – Fluad, Begripal (sold as Aggripal in Italy), Influpozzi Adiuvato and Influpozzi Subunita. Switzerland has suspended deliveries of flu vaccines from Novartis. No adverse reactions have been reported.
  • Food Safety Notification (EU #2012.1488): Listeria monocytogenes in chilled smoked salmon from Lithuania; distributed to Italy.
  • Food Safety Notification (EU #2012.1489): Mercury in crayfish from Tunisia; distributed to France.
  • Food Safety Notification (EU #2012.1490, 2012.1491, 2012.1493, 2012.1494): Defective packaging of canned milk powder from the Netherlands; distributed to China, the Netherlands, Pakistan, Turkey and Vietnam.
  • Food Safety Notification (EU #2012.1492): High aluminum content in vermicelli from South Korea, via the Netherlands; distributed to Germany.
  • Food Safety Notification (EU #2012.1497): Imizol in chilled offals from Sweden; distributed to Denmark and Sweden.

Asia, Africa and the Pacific Islands

  • Food Safety Recall (South Korea/Taiwan): The Taiwan Department of Health orders the recall of Neoguri Seafood & Mild Noodles and Neoguri Seafood & Spicy Noodles after the Korea Food and Drug Administration orders the recall of six instant noodle products made by Nongshim Co., due to the presence in these products of the carcinogen benzopyrene.
  • Food Safety Notification (EU #2012.1490, 2012.1491, 2012.1493, 2012.1494): Defective packaging of canned milk powder from the Netherlands; distributed to China, the Netherlands, Pakistan, Turkey and Vietnam.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.