Contaminated Heparin distributed earlier than originally thought

New information is emerging in the ongoing saga of Heparin contamination. Baxter, the largest distributor of contaminated Heparin, represented on several occasions that the earliest date of distribution of its contaminated products is September of 2007.  Scientific Protein Laboratories (SPL), the manufacture of Heparin API that was contaminated with Over Sulfated Chondroitin Sulfate (OSCS), for the most part has not issued a statement concerning when Heparin which contained OSCS was introduced into the market.  Baxter had about 50% of the market, and AAP had most of the rest of the market.

New information has emerged that manufacturers other than Baxter received contaminated crude Heparin from SPL as far back as 2006, much earlier than when Baxter reports it received Heparin containing OSCS. Specifically B. Braun Medical and Tyco Healthcare (now Covidien) received contaminated Heparin from SPL as early as 2006.

Both companies have issued recalls of the contaminated product. Details of both recalls, including the products affected can be found in the Heparin Contamination article published on our Medical Injury Lawyer website.

Acne cream recalled for bacterial contamination

CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at WalMart).

These products are being recalled because samples of the products were found to contain bacteria identified as "Burkholderia Cepacia," formerly known as Pseudomonas Cepacia.

After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems.

Infants' Mylicon Gas Relief Dye Free Drops Recalled Due To Possible Metal Fragments in Bottles

Johnson & Johnson - Merck Consumer Pharmaceuticals Company has recalled approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. Infants' MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The company is initiating the recall in consultation with the U.S. Food and Drug Administration (FDA). Although the company claims the potential for serious medical events is low, they are implementing the recall to the consumer level as a precaution after determining that some bottles could include metal fragments from the manufacturing process.

According to a joint press release issued by Johnson & Johnson - Merck, any medical events that might occur as a result are expected to be temporary and resolve without medical treatment. However, the absence of manufacturing controls that would have prevented the contamination in the first place, may leave consumers justifiably doubtful of the risk assessment.

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When any foreign contaminant is ingested by an infant, there may be risk of injury.  Parents who have given the product to their infant and are concerned should contact their health care provider immediately. If this defective product was administered to your child and your child suffered medical complications or injury as a result, you may be entitled to claim compensation from those responsible. An experienced medical injury lawyer can explain your options.

The two lots of Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Product Code # Lot # Expiration Product
71683791111-1 SMF007 09/2010 Infants' Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.
71683791111-1 SMF008 09/2010 Infants' Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

The recall does not affect any Original Infants' MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size). The manufacturer has instructed retailers and wholesalers to return their inventories.

Ethex Corp recalls five generic products that pose life-threatening overdose risk

Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products:

  • Propafenone HCl Tablets
  • Isosorbide Mononitrate Extended Release Tablets
  • Morphine Sulfate Extended Release Tablets
  • Morphine Sulfate Immediate Release Tablets
  • Dextroamphetamine Sulfate Tablets

The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences.

Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's drug recall notice for specific lot numbers of the products affected by this recall.

The side effects associated with these dangerous drugs are serious and life threatening. Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately. If you are a loved one have been serious injured by one of these defective pharmaceutical drugs, you should contact a medical injury lawyer to learn more about your options for claiming compensation you may be due.

ReliOn syringes sold by WalMart and Sam's Club recalled for potentially deadly defect

Covidien has recalled ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death.

These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes.

FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

If you or a loved one has been injured by this defective pharmaceutical product, you may be entitled to compensation. A medical injury lawyer can help you hold them accountable.  Contact a medical injury lawyer at Arnold & Itkin LLP. We can answer questions and help you understand your options.

Doctor who injected fake Botox goes to prison

A Houston physician who committed medical malpractice and was convicted last year of injecting her patients with a Botox substitute has started serving her two-year federal sentence. Although she said the fake injections were a "mistake", Dr. Gayle Rothenberg was found guilty of conspiracy, nine counts of mail fraud, misbranding a drug for sale, and lying to federal agents. The doctor and her husband, lawyer Saul Gower, were accused of substituting the cheaper Botulinum Toxin Type A for the FDA-approved product Botox.  The Type A product is similar but isn't approved by the FDA for human use.

The conviction is just another among several obtained as a result of an ongoing investigation by the FDA's Office of Criminal Investigation. "Someone who abuses a position of trust for financial gain and subjects patients to unknown safety risks from unapproved medications will be held accountable," says Kim A. Rice, FDA Special Agent in Charge of OCI's Metro Washington Field Office. "FDA will aggressively pursue those who willfully circumvent laws that are in place to protect the consuming public."

If you have been administered an unapproved substitute for Botox or any other FDA-approved product, you may be entitled to claim compensation for medical malpractice. If you have questions, contact a medical malpractice lawyer to learn more about your options.

Read more about how the FDA is cracking down on Botox scammers and about the FDA's investigation of Illegal Botox-substitution scammers.

FDA warns of fire, explosion, toxic exposure risk with Battery Operated Lavage System (BOLS)

Today the FDA issued a safety alert to notify healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems’ (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursing units. The cutting of the battery pack's cable can lead to a short circuit, causing the batteries to discharge rapidly, producing intense heat and flammable gases with a resulting explosion that expels flammable gases and toxic chemicals endangering both patients and staff.

Read the complete MedWatch 2008 Safety summary, including a link to the Medical Device Safety alert at FDA.gov.

Diabetes drug Byetta linked to injuries and death

Deaths have been reported in connection with the widely used diabetes drug, Byetta (exenatide), marketed by Amylin Pharmaceuticals and Eli Lilly & Co.  An alert from the FDA said they have received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta.  Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at the time of reporting.  Byetta was discontinued in all 6 cases. Federal regulators are working on a stronger label fo the drug.

If you or a loved one have been seriously injured by a defective pharmaceutical drug like Byetta, you may be entitled to compensation from those responsible for your injury. Contact the medical injury lawyers at the Arnold & Itkin LLP law firm in Houston, Texas to learn more about your options.

Heparin death toll increases to 81

The FDA confirmed today in a media briefing on the recall of contaminated Heparin that a total of 81 deaths are now known to have occurred as a result of adverse reactions to the contaminated product. The new total is an increase over the previously reported number of 62 deaths.

The FDA has also announced that Heparin's active ingredient was contaminated at Chinese manufacturing facilities where it was made, with a chemically altered form of chondroitin sulfate, a dietary supplement made from animal cartilage that is widely used to treat joint pain.

Laws in most states provide for several personal injury claims for persons who have been seriously injured due to defective prescription drugs and treatments.  If you are a loved one have been seriously injured by a defective product like contaminated Heparin, you can learn more about options for claiming compensation from those responsible for your Heparin injury.

Contact a medical injury lawyer from the Arnold & Itkin LLP law firm in Houston, Texas. We can answer questions and help you understand your options.

Contaminated Heparin connected with potentially fatal side effects

The FDA announced that Baxter International's popular blood thinning drug Heparin was contaminated with oversulfated chondroitin sulfate.  Hundreds of adverse reactions have been reported in connection with the contaminated Heparin products. At least 19 people have died as a result.

Adverse reactions include refractory hypotension leading to organ damage, organ failure, shock, and death. Baxter began recalling Heparin products in January 2008 and by February 2008 had expanded the recall to include most Heparin products.

More information on the Heparin recall, including options for persons injured by the contaminated drug can be found on our Medical Injury Lawyer website.