New England Compounding Center has recalled all lots of all medications, including potentially tainted epidural steroid injections. The products may be contaminated with fungus, which has caused a non-contagious outbreak of fungal meningitis. Government health officials say that the outbreak has caused at least a dozen deaths, and hundreds of people have fallen seriously ill with meningitis.
January 2, 2012 — At least 620 people have fallen ill and 39 have died. NECC has filed for bankruptcy and will seek to establish a compensation fund for the victims. Click here to read more.
November 26, 2012 — The current case count from the CDC involves 490 cases of fungal meningitis, 12 peripheral joint infections, and 34 deaths in 19 states.
November 12, 2012 — NECC has expressed support for centralization of nationwide fungal meningitis lawsuits into one court. The CDC reports 438 people have fallen ill and 32 have died in 19 states. Click here to read more.
November 5, 2012 — The nationwide total is 419 illnesses (including 10 joint infections) and 30 deaths in 19 states. As the incubation period ends, it is likely that the number of new cases will taper off. However, people with the disease may continue to require treatment for several months or more.
October 26, 2012 — The outbreak of fungal meningitis continues to spread, with more cases of joint infections. The CDC reports a total of 338 infections, including 7 peripheral joint infections and 331 cases of meningitis, stroke, or central nervous system infection. Of these, at least 25 people have died in 18 states.
October 25, 2012 — The CDC is reporting 328 infections linked to contaminated medicines (including 5 peripheral joint infections and 323 cases of fungal meningitis, stroke, or infection) including 24 deaths in 18 states.
October 24, 2012 — The CDC reports that, nationwide, 317 people have been infected (312 cases of fungal meningitis, stroke, or central nervous system infection, and 5 cases of peripheral joint infections), 24 people have died in 17 states. CDC is reporting that new cases are more mild. It has been more than 1 month since NECC medicines were recalled; fungal meningitis has an unknown incubation period and illnesses could continue.
October 23, 2012 — The number of cases of fungal meningitis has grown to 308 (including 304 cases of fungal meningitis, stroke, or other central nervous system infection, and 4 cases of peripheral joint infections). Of these, 23 people have died in 17 states.
October 22, 2012 — The CDC is reporting that the number of illnesses has grown to 297 (including 294 cases of fungal meningitis and 3 peripheral joint infections) and 23 deaths. The number of states involved remains at 16.
October 19, 2012 — The CDC is reporting that, nationwide, 271 people have fallen ill (including 268 cases of fungal meningitis or stroke, and 3 joint infections). Of these, at least 21 have died. 16 states are involved in the outbreak.
October 18, 2012 — Nationwide, 257 people in 16 states have fallen ill (including 254 with fungal meningitis, stroke, or infection, and 3 with peripheral joint infections), and 20 people have died.
October 17, 2012 — According to the CDC, 247 people have fallen ill (including 245 cases of fungal meningitis, stroke, or other central-nervous system fungal infection; and 2 joint infections). Of these, 19 people have died in 15 states.
October 16, 2012 — Nationwide, 233 people have been infected — including 231 cases of fungal meningitis and 2 cases of joint infections. At least 15 people have died in 15 states.
October 15, 2012 — The FDA has identified 3 possible cases of fungal infections caused by other medicines from New England Compounding Center (NECC). The other medicines are triamcinolone acetonide (a type of epidural steroid shot) and cardioplegic solution (commonly used during heart surgery). Click here for more information.
New England Compounding Center Recall
Several government agencies are coordinating a response to an outbreak of fungal meningitis linked to New England Compounding Center. The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and many state health departments have identified more than 100 illnesses and a dozen deaths. The outbreak has been linked to epidural steroid injections sold by the company.
New England Compounding Center voluntarily recalled the steroid shots on September 26, 2012. On October 5, 2012, the company expanded the recall to include all medications sold by the company — around 1,200 medications in total.
The company has also shut down operations and surrendered their pharmacy license.
The company sold at least 17,000 potentially tainted steroid shots to 75 clinics in 23 states (listed below). The CDC estimates that around 13,000 people may have been injected with the recalled products since the outbreak began in May.
What is a compounding pharmacy?
Compounding pharmacies are like modern-day apothecaries. They mix custom medications, usually when there are no commercial alternatives. For example, a compounding pharmacy might make a liquid medication from a solid medication for someone who can’t swallow. Or, they might remove an ingredient from a medication for patients who have allergies.
Many years ago, compounding pharmacies were small-scale operations that mostly provided made-to-order medications. Today, many compounding pharmacies are mass-producing medications and selling them wholesale in bulk — like small pharmaceutical companies. The advantage is that a compounding pharmacy can often provide the drug more cheaply than a pharmaceutical company. Another advantage is that compounding pharmacies can fill prescriptions when there are drug shortages.
Does the FDA regulate compounding pharmacies?
Compounding pharmacies are subject to far less government oversight than pharmaceutical companies. They exist in a regulatory gray area between the federal U.S. Food and Drug Administration (FDA) and 50 different state pharmacy boards. The FDA doesn’t provide much oversight for compounding pharmacies. The FDA is not required to inspect facilities, and the pharmacies do not need to prove their products are safe or effective before they can sell them across state lines. Compounding pharmacies must be licensed by state pharmacy boards, however, many experts say these boards do not have the resources or expertise to inspect or regulate thousands of compounding pharmacies.
Facilities that Recalled Products from New England Compounding Center
The CDC has provided the following list of clinics that received potentially tainted epidural steroid injections from New England Compounding Center:
|CYPRESS SURGERY CENTER DBA||559 740 4094||VISALIA||CA|
|ENCINO OUTPATIENT SURGICENTER||818-986-1037||ENCINO||CA|
|UKIAH VALLEY MEDICAL CENTER||707 463 7345||UKIAH||CA|
|UNIVERSAL PAIN MANAGEMENAT||661-267-6876 x166||PALMDALE||CA|
|INTERVENTIONAL SPINE AND SPORTS MED||203 598 7246||MIDDLEBURY||CT|
|FLORIDA PAIN CLINIC||352-237-5906||OCALA||FL|
|INTERVENTIONAL REHAB 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|
|FORSYTH STREET AMBULATORY SURG. CTR.||478-749-1610||MACON||GA|
|PAIN SPECIALISTS OF IDAHO||208 522 7246||IDAHO FALLS||ID|
|WALTER KNOX MEMORIAL HOSPITAL||208-365-3561 x3342||EMMETT||ID|
|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|
|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|
|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 NEUROSURGICAL INST.||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|
|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|
|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|
|DR. O’CONNELL’S PAIN CARE CTR||603-335-5070||MERRIMACK||NH|
|DR. O’CONNELL’S PAINCARE CENTERS, INC||603 692 3166||SOMERSWORTH||NH|
|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|
|SAHARA SURGERY CENTER||702-362-7874||LAS VEGAS||NV|
|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|
|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 REHAB. CENTER, INC.||DUBLIN||OH|
|ALLEGHENY PAIN MANAGEMENT||814-940-2000 X 500||ALTOONA||PA|
|SOUTH HILLS PAIN & REHAB ASSOC.||412 469 7722||JEFFERSON HILLS||PA|
|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|
|INTERVENE MD||843-216-4844||MOUNT PLEASANT||SC|
|PCA PAIN CARE CENTER-||865 835 5196||OAK RIDGE||TN|
|SPECIALTY SURGERY CENTER||931-484-2500 x125||CROSSVILLE||TN|
|ST. THOMAS OUTPATIENT NEUROSURGIACL||615 341 3433||NASHVILLE||TN|
|DALLAS BACK PAIN MANAGEMENT||214 445 5077||DALLAS||TX|
|HARRIS METHODIST SOUTHLAKE CENTER||817 748 8778||SOUTHLAKE||TX|
|INSIGHT IMAGING-ROANOKE||540 581 0882||ROANOKE||VA|
|NEW RIVER VALLEY SURGERY CENTER||540 639 5888||CHRISTIANSBURG||VA|
|PARS INTERVENTIONAL PAIN||304 865 7277||PARKERSBURG||WV|