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News Archives

August 31, 2018: FDA Announces Recall Montelukast Tablet Recall For Incorrect Drug In Bottles

FDA Montelukast Tablet Recall Announcement The U.S. Food and Drug Administration(FDA) is warning consumers and health care professionals of a recall for one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., of Piscataway, N.J. According to the FDA announcement, the Montelukast Tablet Recall was initiated because sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg. FDA Statement Regarding The Montelukast Tablet Recall This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood Read More

August 27, 2018: Accord Healthcare Recalls Hydrochlorothiazide Tablets – One Lot

Accord Healthcare Recalls Hydrochlorothiazide Tablets Accord Healthcare Inc., has recalled one lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, due to a potential product labeling error. Specifically, a 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg was found to contain 100 Spironolactone Tablets USP 25 mg, according to the company’s recall announcement. Accord Healthcare became aware of the mix-up through a product complaint reported from a pharmacy. About Spironolactone and Hydrochlorothiazide Accord Healthcare provided the following medication information to consumers: “Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure. Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in Read More

August 8, 2018: Nasal Spray Recall – CVS Health 12 Hour Sinus Relief Nasal Mist is Recalled Due To Bacterial Contamination

Nasal Spray Recall Announced – Product Quest Manufacturing of Holly Hill, Fl, has recalled Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, because the product was found to be contaminated with the potentially pathogenic bacterium, Pseudomonas aeruginosa. The product recall announcement for CVS Health 12 Hour Sinus Relief Nasal Mist contained the following risk statement: “Repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immuno-compromised.” Nasal Spray Recall Product Information CVS Health 12 Hour Sinus Relief Nasal Mist is used as a nasal decongestant. The recalled product is packaged in a 0.5 fluid ounce bottle that is placed in an individual folding carton (IFC), bearing Lot # 173089J and EXP 09/19. According Read More

July 6, 2018: Pseudomonas Contaminates Baby Wash – Saje Splish Splash Gentle Baby Wash

Pseudomonas Contaminates Baby Wash – Recall Announced On July 6, 2018, Saje Natural Wellness warned consumers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may be contaminated with the potentially pathogenic bacteria, Pseudomonas aeruginosa. About Pseudomonas aeruginosa According to the CDC, Pseudomonas aeruginosa is an opportunistic pathogen, usually causing infections in people in the hospital and/or with weakened immune systems. Pseudomonas infection in this population can result in septicemia and pneumonia. The CDC reports that Pseudomonas aeruginosa can also infect healthy individuals, “…healthy people can also develop mild illnesses with Pseudomonas aeruginosa, especially after exposure to water. Ear infections, especially in children, and more generalized skin rashes may occur after exposure to inadequately chlorinated hot tubs or swimming pools. Eye infections Read More

August 3, 2018: FDA Warns For Increased Risk of Cancer Relapse With Long-term Use of Azithromycin After Stem Cell Transplant

Azithromycin Safety Announcement – In a Safety Announcement dated August 3, 2018, The U.S. Food and Drug Administration (FDA) warned that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. The announcement was made after results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. The FDA is reviewing additional clinical data regarding this matter, and will communicate their findings and recommendations when the review is complete. Azithromycin Manufacturer Issues “Dear Healthcare Provider Letter” The FDA Safety Announcement stated: “The serious lung condition for which long-term azithromycin was being studied called bronchiolitis obliterans syndrome is caused by inflammation and scarring in Read More

July 28, 2018: Lipari Foods Issues Sandwich Recall For Potential Listeria Contamination

Sandwich Recall Announcement In a press release dated July 28, 2018, Lipari Foods, LLC, announced a recall for its “Premo Brand” and “Fresh Grab” Brand Turkey and Swiss submarine sandwiches, because the products may be contaminated with the bacterial pathogen, Listeria monocytogenes. The recalled sandwiches were produced and packaged by sister company JLM. About Listeria Food Poisoning According to the FDA “Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.” Sandwich Recall Information The recalled sandwiches were produced on July 17, 2018, and distributed to food service and retail stores throughout Florida, Illinois, Read More

July 13, 2018: FDA Announces Valsartan Recall Due To Detection Of Impurity

Detection Of Impurity Prompts Valsartan Recall On July 13, 2018, the FDA alerted health care professionals and patients of a recall for multiple drug products containing the active pharmaceutical ingredient, valsartan, because the products contained an impurity known as N-nitrosodimethylamine (NDMA). Not all products containing valsartan are subject to the valsartan recall. The FDA cautioned that “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.” Valsartan Recall Information for Patients and Health Care Professionals Valsartan is prescribed to treat high blood pressure and heart failure. The FDA has provided health care professional and the public with the following safety information. Patients should neither start nor stop taking Read More

April 6, 2018: Public Health Officials Investigate NJ E Coli Outbreak

The Weinberg Law Firm, located in New Brunswick, NJ, is currently assisting victims of food poisoning outbreaks, including the current NJ E. coli outbreak that may be linked to Panera Bread. If you or a loved one was injured in this outbreak, and you would like information regarding an E. coli lawsuit, please contact the Weinberg Law Firm at 877-934-6274. Our phones are answered 24/7. NJ Department of Health Investigates NJ E Coli Outbreak Cases Here in New Jersey, public health officials are investigating an E. coli food poisoning outbreak that has left at least 8 people hospitalized. Five of those individuals have been discharged. The number of E. coli illnesses reported by NJ County is as follows: Hunterdon (4), Middlesex (1), Somerset (1), and Warren (1). The NJ Department of Health (NJDH) announced on April 6, 2018, that it Read More

February 22, 2018: FDA Cautions – Potential For Increased Long-term Risks With Clarithromycin Use In Patients With Heart Disease

FDA Cautions – Potential For Increased Long-term Risks With Clarithromycin Use In Patients With Heart Disease In a Safety Announcement dated February 22, 2018, the U.S. Food and Drug Administration (FDA) advised caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. The FDA based its recommendations on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue. The FDA has added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in these patients. The study results were also added to the clarithromycin drug labeling. The FDA will continue to monitor safety Read More

February 15, 2018: Apace Packaging Issues Acyclovir Recall For Product Mix-Up

Apace Packaging Announces Acyclovir Recall – On February 15, 2018, Apace Packaging LLC issued a recall for one lot of Acyclovir Tablets due to a product mix-up. According to the company announcement, blister cards containing Acyclovir (400 mg) Tablets may also include Torsemide (200 mg) Tablets. Acyclovir Recall – Product Information Product covered by the Acyclovir Recall can be identified as follows: Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15 (Carton), NDC# 50268-061-11 (Blister Card), Lot Number 19900, to the Retail level. The Apace Packaging recall announcement stated: “Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated. Unintentional dosing of Torsemide, 20mg, Tablets could cause excessive urination. Serious adverse events reported in the clinical studies, for which a drug relationship could not be excluded, were atrial fibrillation, chest pain, diarrhea, digitalis intoxication, gastrointestinal Read More

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