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Defective Medical Products

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Medical Product Recalls

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

As a public service, Pritzker | Ruohonen & Associates, P.A., a leading personal injury law firm, is providing the following chronological list of Food and Drug Administration (FDA) recalls of defective medical products that could cause serious injuries. We have also included some FDA safety alerts. Read more about legal representation for a defective medical product case.

Hydromorphone Recall
ETHEX Corporation has recalled a single production lot of Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04), as a precaution, due to the possibility it may contain oversized tablets. Read about a Hydromorphone recall

KV Pharmaceutical Suspends Shipment of Tablets
KV Pharmaceutical has advised the U.S. Food and Drug Administration that, effective midnight Dec. 19, 2008, the company voluntarily suspended shipments of all FDA-approved drug products in tablet form. Read about a KV Pharmaceutical lawsuit and the suspention of Benazepril, Buspirone, Dextrophetamine, Doxazosin, Isosorbide, Metoprolol, Morphine Sulfate, Ondansetron, Oxycodone, Potassium Chloride, and Propafenone.

Medtronic Defibrillator Lead Recall
Medtronic has removed its Sprint Fidelis defibrillator leads from the market because they may fracture, which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Some deaths, at least 5, and major complications have occurred after the leads have fractured. Read more about the Medtronic Lead recall and a Medtronic lawsuit.

Total Body Formula "Recall"
CDC and FDA have linked cases of renal failure (kidney failure), hair loss, fingernail loss, elevated hepatic enzymes, thrombocytopenia, hemolysis, changes in thought processes, gastrointestinal disorders, chest pain, erythema/flushing/rash, dizziness, headache, agitation, and rhabdomyolysis to Total Body Formula and Total Body Mega Formula, dietary supplements manufactured for Total Body Essential Nutrition, Inc. Read more about the Total Body Formula "recall" and a possible Total Body Formula lawsuit.

Selenium Poisoning (Toxicity)
Total Body Formula, a dietary supplement, has been found by FDA to contain hazardous levels of selenium (up to 200 times the label value). Read about selenium poisoning (toxicity) and a possible Total Body Essential Nutrition, Inc. lawsuit.

Chromium Poisoning (Toxicity)
Total Body Formula, a dietary supplement, has been found by FDA to contain hazardous levels of chromium. Read about chromium poisoning (toxicity) and a possible Total Body Essential Nutrition, Inc. lawsuit.

Fentanyl Patch Recall
Actavis Inc. has announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States. Read about the Fentanyl patch recall.

Tysabri Liver Damage and Wrongful Death
TYSABRI® may have caused severe liver injury that could lead to death or the need for a liver transplant. In a February 2008 “Dear Healthcare Professional Letter,” Biogen Idec, Inc., Elan Corp. and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurring as early as six days after the first dose of Tysabri. A Tysabri lawsuit may include a product liability claim and a Tysabri lawyer can explain a medical malpractice claim.

Botox Wrongful Death
FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B (botox) for both FDA-approved and unapproved uses. At least 23 people have died, most of them children treated for cerebral palsy-accociated limb spasticity.Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. Read about botox wrongful death and the lack of a botox recall.

Colchicine "Recall"
On February 6, 2008, the U.S. Food and Drug Administration (FDA) announced its intention to take enforcement action against companies marketing unapproved injectable colchicines. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Read more about the colchicine "recall" and lawyer information.

Baxter Healthcare Heparin Recall
Baxter Healthcare and FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Read more about the Heparin recall and a Baxter Healthcare lawsuit.

Edetate Disodium Error
There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Read more about a Edetate Disodium (Endrate) error and malpractice.

Recall of Heparing Syringes Due to Possible Contamination with Serratia Marcescens
AM2 PAT, Inc. has recalled one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes have been found to be contaminated with Serratia marcescens, which have resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product. Read about the Heparin recall and a possible Heparin/AM2 PAT lawsuit.

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Cryptosporidium in Minnesota Infant Prompts Recall of Baby's Bliss Gripe Water, Apple Flavor
Baby's Bliss Gripe Water, apple flavor, has been recalled due to possible contaminated with cryptosporidium, a parasite that can cause life-threatening intestinal infections in infants. FDA confirmed through laboratory analysis the presence of cryptosporidium after investigating the illness of a 6-week-old infant in Minnesota who consumed the product. Read more about the Baby's Bliss Gripe Water recall due to possible contamination with cryptosporidium.

Deaths Prompt New Warnings for Haldol (Haloperidol)
The WARNINGS section of the prescribing information for Haldol (haloperidol, an antipsychotic medication), a Johnson & Johnson product, has been revised to include a new cardiovascular (heart-related) subsection regarding cases of sudden death, QT prolongation and torsades de pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Read more about haloperidol and a Haldol (haloperidol) lawsuit.

Deaths Prompt Cephalon to Inform Doctors about FENTORA
There have been serious, adverse events, including deaths in patients treated with FENTORA (fentanyl buccal tablet). According to the manufacturer of FENTORA, Cephalon, “These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution.” Read FENTORA lawsuit and lawyer information.

Xolair: New Boxed Warning
Anaphylaxis (severe allergic reaction) has occurred in some patients who were administered Xolair, an asthma medication manufactured by Genentech, Inc. 15% of the reported cases required hospitalization. Learn about a Xolair lawsuit.

Ceftin, Fortaz, Rocephin, and Zinacef: New Label Precautions and Warnings
Ceftin, Fortaz, Rocephin, and Zinacef (cephalosporin-based antibiotic medications) can cause pseudomembranous colitis, severe inflammation in areas of the colon (large intestine). Children are particularly susceptible to developing antibiotic-related colitis, which can cause serious illness and death. Read Ceftin, Fortaz, Rocephin, and Zinacef lawsuit informtation.

Infant Deaths May Be Linked to Rocephin
Rocephin (ceftriaxone sodium) may be linked to the deaths of newborn infants. The babies most at risk are premature infants who are hyperbilirubinemic (a condition associated with jaundice). As a result, Roche, the manufacturer of Rocephin, issued a letter to healthcare professionals warning of the potential risk and advising them of Roche’s update to the Rocephin for injection prescribing information. Learn more about Rocephin and the risk of death or injury.

Patient Death May Be Linked to Colistimethate (Marketed as Coly-Mycin M and Generic Products)
The FDA has received a report about the death of a patient with cystic fibrosis (CF) who used the antibiotic Colistimethate that had been premixed by a pharmacy into a liquid for inhalation with a nebulizer. Colistimethate (marketed as Coly-Mycin M and generic products) is FDA approved only for injection into a vein or a muscle; it is not FDA approved for use as a liquid to be inhaled via nebulizer. When Colistimethate is mixed into a liquid form, the product begins to break down into other chemicals that can damage lung tissue. Learn more about Colistimethate.

COMPLETE MoisturePLUS Recall
Advanced Medical Optics, Inc. has recalled COMPLETE® MoisturePLUS(TM) multipurpose contact lens care solution. This contact lens solution has been associated with Acanthamoeba keratitis, a rare but serious eye infection. Learn more about the COMPLETE MoisturePLUS recall. Read the FDA notification regarding the AMO Complete MoisturePlus recall.

ApotheCure-compounded Colchicine Recall
3 people in Oregon and Washington may be dead after injections of Colchicine that was compounded by ApotheCure, a Texas pharmacy company. ApotheCure may have compounded the injectionable Colchicine to be far stronger than it should have been (possibly ten times stronger). Read more about ApotheCure and a possible Colchicine lawsuit.

Boston Scientific / Guidant Defibrillator Recall
On April 5, Boston Scientific/Guidant recalled approximately 73,000 Guidant Implantable Cardiac Defibrillators (ICDs) and Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). A faulty capacitor in these devices can cause the batteries to deplete sooner than expected. Learn more about Guidant lawsuit information and the Guidant defibrillator recall.

Zelnorm Heart Attack and Stroke Warning
Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Learn more about Zelnorm heart attack and stroke.

Accutane (Isotretinoin)
The FDA is warning consumers about Accutane (isotretinoin), an acne medication. The warning also applies to generic brands of isotretinoin, Amnesteem, Claravis, and Sotret. According to the FDA warning, Acutane can cause serious injury or death, including birth injuries and death, strokes, seizures and other serious conditions. Learn more about Accutane lawsuits

Pseudomonas aeruginosa: DermaFreeze365™ Instant Line Relaxing Formula

March 23, 2007 - Woodridge Labs, Inc., has voluntarily recalled all lots of its DermaFreeze365™ Instant Line Relaxing Formula (UPC Codes 6-05923-36501-6, 6-05923-36502-3 and 6-05923-10563-6) and DermaFreeze365™ Neck & Chest (UPC Code 6-05923-36503-0) products. This recall was a result of certain limited lots testing positive for the Pseudomonas aeruginosa bacteria. Learn more about the recall of DermaFreeze365.

3 Infants Die Due to Medication Error
Two Heparin products with similar blue labeling are being mistaken for each other. One product delivers 10,000 units/mL of Heparin and the other product delivers only 10 units/mL. In three instances, infants died after being given the 10,000 units/mL product instead of the 10 units/mL product. Learn more about medication errors and Heparin.

Topical Anesthetics
February 6, 2007 – FDA is issuing this advisory to alert you to the potential hazards of using skin numbing products, also known as topical anesthetics, for cosmetic procedures. These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. At least 2 women died after application of topical anesthetics. Learn more about the FDA public health advisory regarding topical anesthetics.

Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT)

December 8, 2006 – Heparin sodium injections can cause Heparin-induced Thrombocytopenia (HIT), a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as Heparin-induced Thrombocytopenia and Thrombosis (HITT). FDA and Baxter International Inc. have notified healthcare professionals that the onset of HIT and HITT may be delayed up to several weeks after the discontinuation of heparin therapy. Learn more about Heparin and HIT and HITT.

Withdrawal of Equate and Member's Mark Wet Wipes
November 17, 2006 -- Rockline Industries announced that it has initiated a voluntary nationwide product withdrawal to the retail level of certain lots of its store brand wet wipes—Equate and Member’s Mark wet wipes sold at Wal-Mart and Sam’s Club. The voluntary withdrawal is a result of routine product testing that detected the presence of a micro-organism known as Burkholderia cepacia (B. cepacia). Learn more about the recall of Equate and Member's Mark wet wipes due to Burkholderia cepacia.

Ortho Evra Birth Control Patch: FDA September 2006 Announcement
Women using the Ortho Evra birth control patch have been shown to have a higher risk for developing blood clots that can lead to heart attack, stroke and other serious health problems. Read FDA September 2006 announcement regarding the Ortho Evra birth control patch.

Donor Referral Services and HIV, Hepatitis B and Hepatitis C
The FDA has notified the health-care community that human tissue recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. Donor eligibility is determined through donor screening and donor testing. A donor is determined eligible to donate tissues only if the results of donor screening and donor testing indicate freedom from communicable diseases or communicable disease risks, including HIV-1 and 2, hepatitis B virus and hepatitis C virus. This means that anyone who received human tissue that originated with Donor Referral Services is at risk for HIV-AIDS, hepatitis B and hepatitis C. Learn more about Donor Referral Services and HIV, hepatitis B and hepatitis C.

Alaris® SE Pumps (formerly the Signature Edition Infusion Pumps)
Alaris® SE Pumps (formerly the Signature Edition Infusion Pumps) may cause serious harm or death. According to Cardinal Health, owner of Alaris Products, a “key bounce” in the Alaris infusion pumps may cause over-infusion of medications, possibly 10 times the amount intended. Upon the request of the FDA, the United States Marshall has seized defective Alaris infusion pumps. Learn more about Alaris SE infusion pumps.

Bismacine (Chromacine) and Bismuth Poisoning
July 21, 2006 – The U.S. Food & Drug Administration (FDA) is warning consumers and health care providers not to use a product called "bismacine," also known as chromacine. The FDA is investigating one report of a death and several reports of injury related to the administration of bismacine. Learn more about the FDA warning regarding bismacine (chromacine) and bismuth poisoning.

Recall of One Lot of Azathioprine
Roxane Laboratories, Inc., has announced a recall of a single manufacturing lot of Azathioprine tablets, USP 50 mg, (NDC 00054-4084-25, Lot 558470A, Exp Mar 2009). It was discovered that a single bottle of Azathioprine tablets from lot 558470A contained Methotrexate tablets USP 2.5 mg. Learn more about the Azathioprine recall.

Disetronic D-TRONplus Power Pack Recall
Disetronic Medical Systems Inc. (Disetronic) of Fishers, IN announced today a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the real potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin delivery is interrupted. An interruption in insulin delivery may lead to uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to serious patient injury and/or death. Learn more about the Disetronic D-TRONplus Power Pack recall.

PIC50 External Monitor/Defibrillator
On July 7, 2006, the FDA announced the recall of 1,184 PIC50 External Monitor/Defibrillators manufactured in Buffalo Grove, Illinois between February 2002 and October of 2004 by MRL, Inc. a Welch Allyn Company. The recalled PIC50 monitor/defibrillators may display a DEFIB COMM ERROR, which may prevent or delay the delivery of therapy, which may fail to resuscitate the patient. Learn more about the PIC50 External Monitor/Defibrillator recall.

Ketek and Liver Failure
Ketek has been associated with cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of Ketek. Ketek is indicated for the treatment of acute exacerbation of chronic bronchitis; acute bacterial sinusitis; and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. Learn more about Ketek and liver failure.

Guidant Pacemaker and Defibrillator Defect
On June 26, 2006, the FDA announced that Boston Scientific, which has recently acquired Guidant, is providing safety information to physicians and patients and retrieving some models of Guidant pacemakers and Guidant defibrillators from its sales force and hospital inventories. Low-voltage capacitors in the affected pacemakers and defibrillators may perform in a manner that leads to device malfunction. Read more about the defective Guidant pacemakers and defibrillators.

Triaminic Vapor Patch Recall
On June 19, 2006, the FDA announced the recall of Triaminic Vapor Patch products. According to the manufacturer, Novartis Consumer Health, serious adverse health effects, including seizures, could result if a Triaminic Vapor Patch is swallowed by a child who has removed the patch to chew on it. Learn more about the Triaminic Vapor Patch recall.

Reusable Ultrasound Transducer Assemblies
On June 19, 2006, the FDA issued a health notification regarding reusable ultrasound transducer assemblies used for various biopsy procedures. These instruments may not have been cleaned properly between uses. If you had a biopsy that involved the use of a reusable ultrasound transducer, you may be at risk for HIV/AIDS, hepatitis B, and hepatitis C. Learn more about biopsy procedures and HIV/AIDS, hepatitis B, and hepatitis C.

Recall of AED20 Automatic External Defibrillators
The Food and Drug Administration (FDA) has announced a June 15, 2006, recall of 580 AED20 automatic external defibrillators. According to the manufacturer, the recalled defibrillators may experience failure or unacceptable delay. Learn more about the recall of AED20 automatic external defibrillators.

Ortho Evra Birth Control Patch Lawsuit Update
The Ortho Evra birth control patch has been linked to numerous cases of stroke, heart attack, and other serious illnesses. In November 2005 the Food and Drug Administration (FDA) approved updated labeling for the Ortho Evra birth control patch to warn healthcare providers and patients that the Ortho Evra birth control patch exposes women to higher levels of estrogen than most birth control pills. The new bolded warning specifically states that women who use the Ortho Evra birth control patch are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. Read the Ortho Evra birth control patch lawsuit update.

Fusarium Keratitis Information
At the request of visitors to this site, we have gather information regarding Fusarium keratitis, the fungal eye infection linked to ReNu with MoistureLoc manufactured by Bausch & Lomb. Information includes an easy-to-understand definition, symptoms, treatment, and a brief explanation of possible product liability and medical malpractice cases. Learn more about Fusarium keratitis.

Bausch & Lomb Recalls ReNu with MoistureLoc
May 15, 2006 – Almost exactly one month after withdrawing ReNu with MoistureLoc from the market, Bausch & Lomb officially recalls the product on a global basis. According to Bausch & Lomb, “unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection.” Learn more about the recall of Bausch & Lomb ReNu with MoistureLoc.

Oral Sodium Phosphate Products (Fleet and Visicol) and Kidney Failure
May 5, 2006 – The Food and Drug Administration is warning health care professionals and patients that a rare, but serious form of kidney failure (acute phosphate nephropathy) has been associated with the use of oral sodium phosphate (OSP) products (e.g., Fleet Phospho-soda solution, Fleet Accu-Prep solution, and Visicol tablets) for bowel cleansing prior to colonoscopy, radiographic procedures, and surgery. Learn more about kidney failure after use of oral sodium phosphate products (Fleet and Visicol)

Renu Recall
We are no longer taking cases related to fungal eye infection outbreak and ReNu with MoistureLoc and ReNu MultiPlus.

COLLEAGUE Volumetric Infusion Pump: FDA Recommendation
April 28, 2006 – The COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation was recalled in July 2005. There was also an urgent correction in December 2005 (with an update in February 2006). The FDA is now recommending that healthcare providers take additional “important safety steps” when using the Baxter infusion pumps. Learn more about Baxter Healthcare's COLLEAGUE Volumetric Infusion Pump.

FDA Warns that Promethazine Can Cause Death in Young Children
April 26, 2006 – The Food and Drug Administration (FDA) has notified healthcare professionals and patients that Promethazine HCI (marketed as Phenergan®, Promacot®, Promethegan®, Promethazine HCI syrup®, and generic products) has been linked to cases of breathing problems, some causing death, when the drug was used in children less than 2 years old. Learn more about Promethazine (marketed as Phenergan and generics).

Recall of Blackstone Medical's ICON Modular Fixation System
In April of 2006, the Food and Drug Administration (FDA) announced a recall of Blackstone Medical’s ICON Modular Fixation System. The ICON Modular Fixation System is used for spinal surgery.According to the recall notification, The construct can loosen in the early postoperative period. This requires surgery to remove the ICON Modular Fixation System. There have been 484 surgical procedures in which the recalled devices have been implanted. Learn more about the recall of Blackstone Medical's ICON Modular Fixation System.

Illegally Harvested Human Tissue Used in Surgical Procedures around the Country

The FDA recalled human tissue, including bones, skin, and tendons used for implants, grafts, and transplants. According to the FDA the tissue was illegally harvested from cadavers at funeral homes in New York City, Rochester, Philadelphia, and New Jersey. 4 officers of Biomedical Tissue Services (BTS) have been charged with illeaglly harvesting the tissue. The tissue was not screened or tested for HIV, Hepatitis B or C, or syphilis. The BTS issue was processed and/or distributed by Regeneration Technologies, LifeCell Corporation, Tutogen Medical, Inc., Lost Mountain Tissue Bank, and Blood and Tissue Center of Central Texas. Medtronic, Inc., of Minneapolis, Minnesota, also used BTS tissue for bone graft products.

Mesh Recall

We are no longer taking cases related to this recall.

Traysylol Poses Risk of Kidney Failure
January 28, 2006—An article in the January issue of the New England Journal of Medicine reported that Trasylol, a popular blood-clotting drug used after heart bypass surgery, poses an increased risk of kidney failure, cardiovascular events, and stroke. Learn more about the risks of Trasylol.

For a selected list of past recalls, please see the following:

See the following for information about defective products and foodborne illnesses caused by contaminated food products:

If you have been seriously injured by a dangerous or defective product, contact a product liability lawyer at Pritzker | Ruohonen for a free consultation regarding your injury. You can reach us toll-free at 1-888-377-8900, email us at info@pritzkerlaw.com or submit your situation for review by our legal counsel with our online consultation form. Our personal injury lawyers obtain some of the largest recoveries for defective product injuries, including a recent settlement for $3,750,000. (The result in this case was based on the facts. The facts of most cases do not support a million-dollar verdict. We aggressively pursue claims no matter how big or small the case is.)

What We Do

Defective Medical Products

Welcome to Pritzker | Ruohonen

Medical Product Recalls

Free Case Consultation

Firm News

Fred Pritzker Listed in The Best Lawyers in America

Medtronic Recall and Medtronic Lawsuit

Fleet Lawsuit

Ortho Evra Lawsuit: Ortho Evra Birth Control Patch

Trasylol Recall

Fentanyl Lawsuit and Fentanyl Recall

Fosamax and Osteonecrosis

NuvaRing Death