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Possibly Underweight Metronidazole Tablets Recalled by Teva Pharmaceuticals

Underweight metronidazole tablets have been recalled by Teva Pharmaceuticals. Taking metronidazole pills that are underweight and lack an appropriate amount of active ingredient could result in a worsening of the infection they are meant to treat, which in some instances could become life-threatening.

Teva said it has not learned of any side effects associated with underweight metronidazole tablets. (more…)

McNeil Consumer Healthcare Faces Investigation Over Recall

A congressional panel is opening an investigation into McNeil Consumer Healthcare’s recent recall of children’s over-the-counter medicines.

The House Committee on Oversight and Government Reform is investigating conflicting accounts of what prompted the recall, as well as McNeil’s handling of consumer complaints. It wants to look at a chronology of events leading up to the recall, as well investigation reports from both McNeil and the Food & Drug Administration (FDA). It also plans to ask the FDA for its procedures governing routine inspections of over-the-counter drug makers and recalls. (more…)

Tylenol, Motrin, Rolaids, Benedryl and St. Joseph’s Aspirin Recalled

Motrin, Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin are being recalled today by Johnson & Johnson unit McNeil Consumer Healthcare because they may be tainted with a chemical that causes a moldy smell, and could cause stomach illness.

Any smell is likely the result of contamination with trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, but McNeil said that so far, to date all of the reported adverse reactions have been temporary and non-serious. (more…)

Tylenol Arthritis Caplets Recalled Over Musty Odor, Illness Reports

Consumer reports of a musty odor, as well as nausea, stomach pain, vomiting and diarrhea have prompted a recall of all product lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP. This is an expansion of a recall McNeil Consumer Healthcare issued in November.

According to McNeil, the uncharacteristic smell associated with recalled Tylenol Arthritis Pain Caplets is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, but McNeil said that so far, to date all of the reported adverse reactions have been temporary and non-serious. (more…)

MedImmune Nasal Swine Flu Vaccine Recalled

MedImmune has a issued a recall of its nasal swine flu vaccine because it may have lost potency.

The recall involves 13 lots of the company’s nasal spray monovalent H1N1 flu vaccine distributed throughout the U.S. The lot numbers involved in this recall can be viewed online here. (more…)

Proctor & Gamble Recalling Vicks Sinex Nasal Spray After Bacteria Detected

Three lots of Vicks Sinex nasal spray are  being recalled in  the United States, United Kingdom and Germany because of potential contamination with the bacteria, B. cepacia.   According to a recall notice issued by Proctor & Gamble,  B. cepacia  has been found in some of  the product made at its plant in Gross Gerau, Germany, and in a small amount of Vicks Sinex nasal spray from the recalled lot sold in the States.

There have been no reports of illness.  However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis.  B. cepacia poses little medical risk to healthy individuals. (more…)

SEC Seeking Info on Zicam Warning

More bad news for Matrixx Initiatives on the Zicam front.  According to a Wall Street Journal report, last week’s Food & Drug Administration (FDA) warning on several Zicam nasal cold remedies seems to have attracted the attention of the Securities and Exchange Commission (SEC).

According to The Wall Street Journal, the SEC has asked Matrixx to provide documents and information relating to the FDA warning.  On Tuesday, the company said it didn’t know what the SEC was looking into but would cooperate fully, the Journal said. (more…)

Zicam Side Effects Raise New Concerns About Homeopathic Drugs

The potential problems of homeopathic medicine were brought into sharp relief last week, when federal regulators warned consumers not to use three Zicam nasal cold remedies.

Homeopathic medicines are very popular.  According to the Associated Press, sales of homeopathic drugs hit $830 million last year.  What’s more, in 2007 such remedies were taken by more than 4 million Americans.  But many consumers who use such products may be surprised at how little these drugs are regulated.  Homeopathic remedies like Zicam do not require  Food & Drug Administration (FDA) approval, and they do not have to be proven safe or effective before going on the market.  However, the agency can intervene when there’s evidence a homeopathic drug may pose a risk to consumers. (more…)

Watson Pharmaceuticals Recalls Oversized Heart Meds

One lot of potentially oversized Propafenone HCL 225 Tablets mg Tablets have been recalled by Watson Pharmaceuticals, Inc because some of them may be oversized.

Watson Pharmaceuticals is uringing nyone who has 225 mg Propafenone HCL Tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled. Anyone with these tablets should call (888) 352-9616, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product. (more…)

FDA Warns of Kidney Problems with Bowel Preps

The U.S. Food and Drug Administration (FDA) just announced it is adding a Boxed Warning to the labeling of prescription oral bowel prep products, and warned about possible kidney problems with over-the-counter versions as well.  Meanwhile, C.B. Fleet Company has announced a voluntary recall of its OTC  Fleet(R) Phospho-soda products.

In 2006, the FDA issued a “Science Paper and a Healthcare Professional” sheet describing the risks associated with the use of oral sodium phosphate OSP products for bowel cleansing. OSPs are generally taken by patients for bowel cleansing prior to certain medical procedures such as colonoscopy. As part of the FDA’s post-marketing surveillance, it has received 20 reports of kidney injury linked to OsmoPrep; three were biopsy-proven cases of acute phosphate nephropathy.  The onset of kidney injury varied, with some occurring within several hours and others within 21 days after using the OSP. (more…)

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