Consumer Lawyers

Archive for June, 2012|Monthly archive page

Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall

In FDA Warning on June 25, 2012 at 8:51 pm

From the FDA site:

Risk of Fire, Loss of Supplemental Oxygen

Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death.

Affected products include serial numbers from 042-10000 through 102-09335. These oxygen concentrators were manufactured from January 1, 2004 to May 15, 2010.

BACKGROUND: Oxygen concentrators are used to supply supplemental oxygen to patients within a home setting.

RECOMMENDATION: The firm sent its distributors a Field Correction notice May 1, 2012, asking distributors to contact customers and/or patients who brought these products. Consumers should notify your equipment provider if you have an affected product in your home or place of business. According to the firm, patients may continue to use the device while waiting for a replacement for the corrected component.
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

Healthy Choice Recalls All Sizes of Liquid Gold Carrot Juice

In Uncategorized on June 25, 2012 at 8:46 pm

Healthy Choice Island Blends, Inc. of Los Angeles, CA, is recalling all sizes of LIQUID GOLD CARROT JUICE including 128oz, 64oz, 32oz, and 16 oz, because it has the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness.

Foodborne botulism is a severe type of food poisoning caused by the ingestion of foods containing the potent neurotoxin formed during growth of the organism. Foodborne botulism can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking, breathing and swallowing. Weakness of other muscles, abdominal distension and constipation may also be common symptoms.

People experiencing these problems should seek immediate medical attention. Consumers are warned not to use the product even if it does not look or smell spoiled.

Liquid Gold Carrot Juice was distributed in California and sold wholesale to produce companies.

Product was sold in plastic see-through containers in gallon, half-gallon, and quart sizes. Product has a white label branded Liquid Gold with picture of carrots and a glass of carrot juice, with UPC Code 7 63213 00130.

No illnesses have been reported to date.

June Mesh News: J and J to stop selling Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M

In Surgical Mesh on June 11, 2012 at 5:38 pm

johnson & Johnson is stopping sales of surgical mesh products that aimed to relieve the intense pelvic pain of thousands of women but resulted in numerous reports of injury and several deaths. They are saying it’s not a product recall, however.

The surgical meshes, sold by J&J’s Ethicon unit, are among a class of products made by various companies whose safety and effectiveness the Food and Drug Administration warned about in 2008.

The company is planning to halt sales world-wide of Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M mesh products, an Ethicon spokesman said. The company has asked the FDA to allow it to keep selling its Gynecare Gynemesh product, but for insertion through the abdomen only, rather than the vagina as is also currently allowed, the spokesman said.

J&J will be stopping sales over the next three to nine months, with the goal of completing the process by the first quarter of 2013, the company spokesman said.

U.S. Has Drug Recall Problem Says a Recent Study

In Uncategorized on June 11, 2012 at 4:24 pm

In a new study, published today in the Archives of Internal Medicine, the researchers found that the FDA issued official public notices for only about half of the recalls deemed the most serious, called Class I recalls.

The FDA offers this communication service, and we anticipate that a lot of providers may rely on it and in doing so may not be getting the information they need when drugs are recalled,” said Joshua Gagne, an epidemiologist at Brigham and Women’s Hospital and one of the authors of the study.

Gagne and his colleagues analyzed eight years of data from the FDA’s Enforcement Reports and the archives of the agency’s two chief drug recall-reporting systems: the Recall Alert System and the FDA MedWatch Safety Alert database. According to the study, FDA records show 1,734 drug recalls from 2004 to 2011; 91 of those recalls were tagged Class I recalls, meaning they had the greatest likelihood to cause patients serious harm,  even death.

Read more:

AOI Cranial Remolding Helmets Warning Letter from FDA

In Uncategorized on June 4, 2012 at 1:44 am

Mr. Mohamad Mansoori
Advanced OrthoPro, Inc.
1820 N. Illinois Street
Indianapolis, IN 46202

Dear Mr. Mansoori:

During an inspection of your firm located in Indianapolis, IN on April 16, 2012, through April 26, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures AOI Cranial Remolding Helmets. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for developing, conducting, controlling, and monitoring production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). Specifically, your firm does not have a documented process control procedure that describes any process controls necessary to ensure conformance to specifications. Although you provided the investigator with a one page document entitled “Helmet Mold Modification Instructions”, which was developed during the course of the inspection, this document does not meet the requirements listed in 21 CFR 820.70(a)(1-5) in that it does not include: 1) instructions, procedures and methods that define and control the manner of production, 2) the monitoring and control of process parameters, and component and device characteristics during production, 3) compliance with specified reference standards or codes, 4) the approval of processes and process equipment, and 5) criteria for workmanship that is expressed in documented standards or by means of identified and approved representative samples.

2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 C.F.R. § 820.50. Specifically, you have not established: 1) specifications for the raw materials used to manufacture the AOI Cranial Remolding Helmet; and 2) criteria for the selection and evaluation of suppliers.

3. Failure to establish and maintain adequate procedures for acceptance of incoming product, which shall be inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b). The FDA investigator was told that there is not an established procedure for the acceptance of the incoming raw materials used to manufacturer the AOI Cranial Remolding Helmets.


FDA Alert: Recall of Dietary Supplement Reumofan Plus

In FDA Warning on June 4, 2012 at 1:42 am

The FDA issued a warning to consumers against using a a Mexican “natural” dietary supplement promoted for pain relief due to unlabeled and potentially harmful pharmaceutical ingredients.

The warning for Reumofan Plus was issued after the agency received a number of adverse event reports, including incidences of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.

After a laboratory analysis, the agency found Reumofan Plus contains the prescription drugs diclofenac sodium and methocarbamol.

Diclofenac sodium is a nonsteroidal anti-inflammatory drug that may cause cardiovascular events such as heart attack and stroke as well as serious gastrointestinal adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines, the FDA said in a statement.

Methocarbamol is a muscle relaxant that can cause sedation, dizziness, hypotension and can impair mental and physical performance to drive or operate machinery.

he U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers should not buy or start using the product.

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).

An FDA laboratory analysis of Reumofan Plus found that it contains:

  • diclofenac sodium – a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines.
  • methocarbamol – a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

These ingredients also may interact with other medications and result in serious adverse events.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

According to FDA adverse events reports, consumers reported symptoms suggesting that some lots of Reumofan Plus may contain corticosteroids. At least one report from a health care professional treating a patient with adverse events from using Reumofan Plus, confirmed adrenal suppression. Abrupt discontinuation of corticosteroids after long-term or high dose use can cause fatigue, nausea, low blood pressure, low blood sugar levels, fever, muscle, and joint pain, dizziness, and fainting.

Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids.

Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.