Johnson & Johnson in trouble again

Johnson & Johnson, a name that has meant clean, honest medical supplies and medicines throughout its 120-year history, was given bad marks in quality control by the FDA at a recent inspection. (See the Wall Street Journal’s report.) 

The company’s McNeil production plant in Fort Washington, Pennsylvania, has been shut down with no definite timeline for re-opening it. This follows an April, 2010, FDA inspection that found problems such as “bacterial contamination of ingredients, filthy equipment and the potential for medicines to be too potent.”

Another serious charge was levied on the company’s Ortho McNeil manufacturing plant. A fine of $6.14 million was levied by the FDA in May of this year on charges that  Ortho McNeail was marketing the Topomax epilepsy drug for psychiatric purposes. The FDA has never approved of Topomax for treating any psychiatric disorders. An affiliate company, Ortho-McNeil-Jansen Pharmeuticals, will pay $75.3 million to cover the cost of claims by members of the public, as allowed by the False Claims Act.

Earlier this year 70 percent of Johnson & Johnson’s over-the-counter children medicines were recalled, with roughly 70 percent of the market for such products pulled from store shelves, including a nationwide recall of Children’s Tylenol. Altogether, more than 40 varieties of liquid medicines, including pain drug Motrin, and allergy medicines Benadryl and Zyrtec, were recalled. The recall is undoubtedly the largest in U.S. history for children’s medication.

These reports are just a few of the many charges of sloppy workmanship aimed at Johnson & Johnson in recent months. While the problems are highly unlikely to result in any physical harm to anyone, experts agree that the public relations impact is huge.

The company seems to be taking the jolts in stride. In a June 4 press release, Johnson & Johnson announced that its “pharmaceutical businesses generated $24.6 billion in sales last year, 39 percent of the company’s total revenue, and ranks as the world’s seventh largest pharmaceutical company and fourth largest biotech company.”

Submitted compliments of Griffith Publishing

Recalled by the FDA

The U.S. Food and Drug Administration has issued a long list of foods that have been recalled by the agency because of possible health problems. Here they are, as of June 1, 2010.

Spice products made with Hydrolyzed Vegetable Protein (HVP). Reason: potential Salmonella contamination.

Seasoning salts manufactured by Dutch Valley Foods. Reason: potential Salmonella contamination.

Crab snack and seasoning manufactured by Watkins. Reason: potential Salmonella contamination.

Austinuts honey and mustard pretzel. Reason: potential Salmonella contamination.

Zatarain’s Original Dirty Rice, by McCormick. Reason: incomplete ingredient statement on the label.

Mama Lycho Queso Duroblando cheese, by Gotera Inc. Reason: possible contamination with Staph aureus.

Orange drink in bulk quantities, by Juice Pac. Reason: label doesn’t list Yellow 5 as an ingredient.

Sea Delight tuna steaks. Reason: elevated histamine levels.

Beef and garlic seasonings by Givaudan. Reason: Salmonella found in production facility.

39 various flavorings by Givaudan. Reason: Risk of Salmonella.

Seasoned southern-style country cabage by Hirzel Canning Company, Ohio. Reason: Swollen cans of lot 6339X1GCCH were found on many pallets while loading a truck for shipment. Testing by an outside lab found Facultative Bacillus sp. (Terminal spores) in the swollen cans and heat stable spore-forming Bacillus species in a sample of can cooling water that was consistent with the organism found in the can.

Turkey/Swiss cheese hoagie sandwiches, by SK Food Group. Reason: Possible contamination by salmonella, later determined to be contamination by a  non-disease causing e.coli organism.

Vericose vein support, liquid form, by Wiseway Herbals. Reason: Contaminated with soap.

Semprex, by UCB Manufacturing. Reason: Impurities and degredation.

Concentrated Tylenol and Motrin, infant drops in a variety of products, by McNeil. Reason: Incorrect or missing lot numbers on label.

Red blood cells, by the American Red Cross. Reason: some blood products were not tested for quality control but were distributed.

Blood plasma, by CSL Plasma Inc. Reason: undocumented physical examination.

Fresh frozen plasma, by American Red Cross (Charlotte, NC). Reason: Blood products were accepted from a donor without adequate determination of donor suitability.

Red blood cells, leukocytes reduced, American Red Cross (Omaha, NB) Reason: Blood products were accepted from a donor without adequate determination of donor suitability. 

Red blood cells, leukocytes reduced, American Red Cross (Columbus, OH). Reason: Blood product accepted from a donor who tested negative for the FYB antigen but later tested positive.

Red blood cells, leukocytes reduced, American Red Cross (Cincinnati, OH). Reason: Blood product accepted from a donor who reported traveling to an area with endemic malaria.

Plasma, recalled by Talecris Plasma Resources because the donor  supplied unreliable information regarding application of tattoos.

Platelets Pheresis Leukocytes Reduced, by LifeSouth Community Blood Centers, Inc., Gainesville, FL. Reason: platelet count below the specified minimum requirement.

Plasma, by DCI Biologicals Texarkana LLC, Gallup, NM. Reason: Collected from a donor who provided unreliable information regarding application of tattoos and piercings.

Red Blood Cells Leukocytes Reduced, by Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH. Reason: distribution or product from a donor who reported travel to a malarial endemic area.

Plasma, by PlasmaCare Inc., Columbus, OH. Blood products from a donor whose physical exam was incomplete.

Source Plasma, DCI Biologicals Texarkana LLC, Texarkana, AR. Reason: Blood products from a donor with high risk behavior.

Plasma, Blood Centers of the Pacific – Irwin Center, San Francisco, CA. Blood productsfrom a donor with a history of hepatitis A.

Platelets Pheresis Leukocytes Reduced, by LifeSouth Community Blood Center, Inc., Gainesville, GA. blood product, with a low platelet count.

Red Blood Cells, by Blood Bank Of Hawaii, Honolulu, HI. Reason: Collected from a donor who traveled to an area considered endemic for malaria.

Red Blood Cells Leukocytes Reduced, by Mid-South Regional Blood Center, Memphis, TN. Reason: collected from a donor who traveled to an area considered endemic for malaria.

Platelets Pheresis Leukocytes Reduced, by ARC Blood Services, New England Region, Dedham, MA. Reason: Distributed product exceeded the acceptable limit for white blood cell count.

Red Blood Cells, by Providence Health System Southern California, Burbank, CA. Reason: Blood product from a donor who was previously deferred for high risk behavior.

Plasma, by CSL Plasma, Racine, WI. Reason: Physical examination of donor was undocumented.

Red Blood Cells Leukocytes Reduced, by Blood Centers of the Pacific – North Bay Center, Fairfield, CA. Reason: Collected from a donor who had traveled to a malarial endemic area.

Red Blood Cells Leukocytes Reduced, by Carter BloodCare, Bedford, TX. Reason: Donor suitability not adequately determined.

Platelets Pheresis Leukocytes Reduced, by Blood Centers of the Pacific – Irwin Center, San Francisco, CA. Reason: Donor had traveled to a malarial endemic area.

Source Plasma, by Biomat USA, Inc., South Bend, IN. Reason: Donor at risk for variant Creutzfeldt-Jakob Disease (vCJD).

Source Plasma, by ZLB Plasma Services, San Antonio, TX. Reason: Donor did not receive a required annual physical.

Red Blood Cells Leukocytes Reduced, by Central Kentucky Blood Center Inc., Lexington, KY. Reason: Donor had traveled to an area considered endemic for malaria.

Red Blood Cells Leukocytes Reduced, by The Blood Alliance, Inc., Jacksonville, FL. Reason: Donor had traveled to an area considered endemic for malaria.

Source Plasma, by BioLife Plasma Services, L.P., Missoula, MT. Donor did not receive a required annual physical.

Source Plasma, by BioLife Plasma Services, L.P., Grand Forks, ND. Donor did not receive a required annual physical.

Red Blood Cells Leukocytes Reduced, by Mississippi Valley Reg. Bld. Center, Davenport, IA. Reason: Donor travel to an area considered endemic for malaria.

Platelets Pheresis Leukocytes Reduced, by Mississippi Valley Regional Building Center, Davenport, IA. Reason: Blood products did not meet acceptable specifications.

Platelets Pheresis Leukocytes Reduced, by Memorial Blood Centers, Saint Paul, MN. Reason: Blood products had an unacceptable white blood cell count.

Red Blood Cells Leukocytes Reduced, by American Red Cross Blood Services, Central Ohio Region, Columbus, OH. Reason: Blood products were not quarantined after receiving information concerning an illness following donation.

Red Blood Cells Leukocytes Reduced, by American Red Cross Blood Services, Central Ohio Region, Columbus, OH. Reason: Donor suitability not adequately determined.

Red Blood Cells Leukocytes Reduced, by American Red Cross Blood Services, Birmingham, AL. Reason: Donor suitability not adequately determined.

Red Blood Cells Leukocytes Reduced, by American National Red Cross Mid Atlantic Region, Norfolk, VA. Reason: Donor suitability not adequately determined.

Red Blood Cells Leukocytes Reduced, by Blood Bank Of The Redwoods, Santa Rosa, CA. Reason: Donor was previously refused for testing positive for the human immunodeficiency virus (HIV).

Red Blood Cells Leukocytes Reduced, by South Texas Blood & Tissue Center, San Antonio, TX. Reason: Donor taking the medication finasteride.

Platelets Pheresis Leukocytes Reduced, by LifeSouth Community Blood Centers, Inc., Dunwoody, GA. Reason: Platelets were not prepared properly, were split into three storage bags instead of two.

Platelets Pheresis Leukocytes Reduced, by LifeSouth Community Blood Centers Inc., Huntsville, AL. Reason: Low platelet count in distributed product. (Three recalls from the same blood center.)

Fenwal PL 2410 Storage Container, by Fenwal Inc., Lake Zurich, IL. Reason: Associated with reports of leaks on the heat seals at the end of the tubing leads.

Human bone, by Allosource, Centennial, CO. Reason: Presence of positive pre-processing cultures for group D Enterococcus.

Red Blood Cells Leukocytes Reduced, by LifeSouth Community Blood Centers, Inc., Gainesville, FL. Reason: not manufactured in accordance to the manufacturer’s instructions .

Platelets Pheresis Leukocytes Reduced, by LifeSouth Community Blood Centers, Mobile, AL. Reason: blood product with a low platelet count. (2 cases)

Platelets Pheresis Leukocytes Reduced, by The American National Red Cross – North Central Region, Saint Paul, MN. Reason: donor suitability not adequately determined.

Red Blood Cells Leukocytes Reduced, by American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR/ Reason: donor suitability not adequately determined.

Influenza A (H1N1) 2009 Monovalent Vaccine, by Sanofi Pasteur, Inc., Swiftwater, PA. Reason: Influenza A (H1N1) 2009 Monovalent Vaccine, with antigen content lower than the specification limit, 960,295 doses distributed.

Red Blood Cells Leukocytes Reduced, by Tri-Counties Blood Bank dba UBS- Central Coast, Santa Barbara, CA. Reason: Labels incorrectly marked as collected from volunteer donors.

Red Blood Cells Leukocytes Reduced Irradiated, by ARC Blood Services, New England Region, Dedham, MA. Reason: blood product manufactured without the additive solution.

Recovered Plasma, by Carter BloodCare, Bedford, TX. Reason: blood product from donor without adequate determination of suitability. Same reason reported for 1 unit each from the following: American Red Cross Blood Services, Central Ohio Region, Columbus, OH; American Red Cross Blood Services, Birmingham, AL; American National Red Cross Mid Atlantic Region, Norfolk, VA.

Recovered Plasma, by Blood Bank Of The Redwoods, Santa Rosa, CA. Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV).

Recovered Plasma, by South Texas Blood & Tissue Center, San Antonio, TX. Reason: donor was taking the medication finasteride.

Red Blood Cells Leukocytes Reduced, by Heartland Blood Centers, Aurora, IL. Reason: Blood products were distributed in expired collection bags.

Source Plasma, by DCI Biologicals Hot Springs, Inc., Hot Springs, AR. Reason: Collected from an ineligible donor.

Prevnar, by Wyeth Pharmaceuticals Inc., Philadelphia, PA. Reason: potential for syringes with a rubber formulation in the tip caps not approved for use, 46,155 units.

Red Blood Cells (Apheresis) Leukocytes Reduced, by South Texas Blood & Tissue Center, San Antonio, TX. Reason: product did not meet acceptable product specifications. Same situation for South Texas Blood & Tissue Center, San Antonio, TX.

Serum iron detection sets, by Pointe Scientific, Inc., Canton, MI. Reason: invalid test results could be sent out due to turbidity formation, 1,082 sets.

Aquilion One Whole Body X-Ray CT Scanner, Whole body computed tomography scanning, by Toshiba American Medical Systems Inc., Tustin, CA. Reason: Delivery of clinical useful images may not be obtained because of incorrect intervals set before starting the scan, 29 units.

Staph latex tests and text kits, by NERL Diagnostics Corp., East Providence, RI. Reason: unattractive staph latex reagent. 

Micro introducer kit. Galt Medical Corp., Garland, TX. Reason: Potential problem with pouch seal thus affecting sterile product, 400 kits.

Distal Centralizer, Exeter II Hip System, by Stryker Howmedica Osteonics Corp., Mahwah, NJ. Reason: device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.

MRI Scanner Compensation Coil, by Hitachi Medical Systems America Inc., Twinsburg, OH. Reason: Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk, 56 devices.

Surgical lights and lighting systems, by Stryker Communications Corp., Flower Mound, TX. Reason: incomplete installation records.

Anterior Cervical Plate System, by Blackstone Medical, Inc., Wayne, NJ. Reason: possible nonconformity in the plate bendeer, causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured, 112 units.

Photopheresis Procedural Kits, by Therakos, Inc., Raritan, NJ. Reason: Higher than normal blood leaks, 280 units in U.S. each with 3 kits.

Radiation Treatment Planning System, by Computerized Medical Systems Inc., Maryland Heights, MO. Reason: Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening, 34 units.

Cardiovascular and fluoroscopic imaging systems, by GE Healthcare, LLC, Waukesha, WI. Reason: potential software failure.

Lyric in-canal hearing aid, by InSound Medical, Inc., Newark, CA. Reason: potential electrolyte leakage from the product’s battery, due to manufacturing error, 2,019 units.

Compression wrap, by Circaid Medical Products Inc., San Diego, CA. Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension applied. The system should have 1.25 inches of space. The correct spacing (1.25″) is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level or discomfort from overtightened bands, 372 units.

Dental prosthetic implant, by 3m Imtec Corp., Ardmore, OK. Reason: incorrect size labeling, 189 units.

The FDA maintains information on drug and medical device recall at this address.

This information comes to you courtesy of Griffith Publishing, where we produce quality books for authors and self-publishers with a special emphasis in medical and health books and newsletters. 1 800 359-95o3.