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

This recall involves one lot, or around 75 bottles, of Metronidazole Tablets USP, 250mg. Each recalled bottle, which contains 250 tablets, bears lot number 312566, and an expiration date of 05/2011. The affected tablets were shipped in May 2009.

Consumers who have lot 312566 in their possession are instructed to cease using the product and return it to their pharmacy. Wholesalers and retailers should cease distribution and examine their inventory immediately.

Metronidazole is indicated for the treatment of symptomatic and asymptomatic trichomoniasis, and treatment of asymptomatic consorts, amebiasis and a variety of anaerobic bacterial infection.

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.

McNeil – a unit of Johnson & Johnson – said it plans to cooperate with the committee’s investigation.

McNeil issued the recall last Friday, saying some drugs might contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. The medications – 43 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid in Bottles – were recalled in the U.S. and 11 other countries.

Yesterday, we reported that the Food & Drug Administration (FDA) cited deficiencies at the company’s Fort Washington, PA facility that could have caused bacterial contamination of raw materials in the recalled products. The agency also charged that McNeil knowingly used bacteria-contaminated materials to make the recalled drugs. The agency also faulted McNeil for failing to initiate corrective action after receiving 46 consumer complaints from June 2009 to April 2010 regarding foreign materials in the drugs.

Earlier, the company said it is making all efforts to correct the problems and has shut down production of 50 over-the-counter medications made at the facility.

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.

Last November, McNeil recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CA because of reports of the odor, which was associated with nausea, stomach pain, vomiting and diarrhea. That recall was expanded in December to include all lots of the product.

Now, McNeil is recalling more products that might be tainted with the same chemical. Since the December recall, the company said it has now applied broader criteria to identify and remove all product lots that may be affected, even if they have not been the subject of consumer complaints. McNeil also said it was ceasing shipment of products produced using materials shipped on the wood pallets and requiring suppliers to stop using the pallets.

The recall involves lots in the Americas, the United Arab Emirates (UAE), and Fiji. A complete list of recalled products is available here, or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).

McNeil has not been able to determine how the chemical may have penetrated product packaging.

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.

Only the Tylenol Arthritis Pain Caplet 100’s with the distinctive red EZ-OPEN CAP are affected by this action. All other Tylenol Arthritis Pain products remain commercially available.

Last month, five lots of the Tylenol Arthitis Pain Caplets were recalled. According to a notice posted on the Food & Drug Administration (FDA) Web site, the original recall is being expanded as a precautionary measure.

McNeil Consumer Healthcare said it will reintroduce the Tylenol Arthritis Pain Caplet 100 count product by January, 2010 after moving production to a new facility

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.

People who received a swine flu vaccine from one of these lots do not need to be revaccinated, MedImmune said. The vaccine potency is only slightly below what it is supposed to be. The vaccine in these lots is still expected to be effective in stimulating a protective response.

Most of the recalled swine flu vaccine was given out in October and November, and would have been fully potent then. About 300,000 doses are left in warehouses. MedImmune is recalling the unused doses.

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.

The three lots of Vicks Sinex nasal spray being recalled are:

• United States:  Lot # 9239028831; Product Name: Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray
• United Kingdom:  Lot # 9224028832l; Product Name: Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml
• Germany:  Lot # 9224028833; Product Name:  Wick Sinex Schnupfenspray Dosiersystem, 15 ml

The lot number is listed on both the outer carton and the bottle.

Proctor & Gamble is  removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  Consumers have been advised to discard the affected product as they would any OTC medicine.

Anyone who has these specific lots of Vicks Sinex nasal spray can call Proctor & Gamble for a replacement coupon or refund at the following numbers:

• From the United States, please call:  1.877.876.7881 (Hours of operation:  Monday – Friday, 9AM – 6PM US ET, Saturday – Sunday, 9AM – 4PM US ET)
• From the United Kingdom, please call:  0800.5555.15 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)
• From Germany, please call:  0800.111.6131 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time

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.

Last week, the FDA said it had received 130 reports of anosmia – loss of sense of smell – in people who had used three Zicam nasal remedies. Following the FDA alert, Matrixx Initiatives recalled two of the products – Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

Zicam  – which also comes in other varieties, such as melting tablets and liquids -is Matrixx’s most popular product line, and accounts for about 40% of its sales.  The recall could cost Matrixx as much as $10 million.  The day of the FDA warning, Matrixx shares closed at $5.78, compared with $19.24 at its close the day before, The Wall Street Journal said. According to a Reuters report, Matrixx began formally notifying retailers, wholesalers and distributors of the Zicam recall today.

However, Matrixx continues to say that it “vigorously disagrees” with the FDA over charges that the Zicam products were illegally marketed. It also continues to maintain that nasal varieties of are safe.  This, despite the fact that  in 2006 the company reached a settlement with 300 Zicam users who claimed the nasal remedies had caused them to lose the sense of smell.

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.

Most American’s who use homeopathic drugs do so with the assumption that they are safe.  But the Associated Press dug up some disturbing facts about these products, including the fact that more than 800 homeopathic ingredients were potentially implicated in health problems last year.

What’s more, many are made with questionable ingredients.  For instance, some homeopathic remedies contain far more alcohol  than what is allowed in traditional medicines.  In fact, the FDA has acknowledged that some homeopathic syrups far surpass 10 percent alcohol.  The Associated Press also found that at least 20 ingredients used in conventional prescription drugs are also used in homeopathic remedies. This includes  digitalis for heart trouble and morphine for pain.  Homeopathic medicines have also been made  from cancerous and diseased tissues, and  poisons such as strychnine, arsenic or snake venom.

The Zicam debacle only highlights the possible dangers of unregulated, homeopathic drugs.  Last week, the FDA said it had received 130 reports of anosmia – loss of sense of smell – in people who had used three Zicam nasal remedies. During a conference call to announce the Zicam alert, the FDA also said Matrixx Initiatives had received an additional 800  anosmia reports it hadn’t made available to the agency.  Following the FDA alert, Matrixx Initiatives recalled two of the products – Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

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.

The Propafenone tablets subject to this recall bear lot #112680A,  and an expiration date  of July 31, 2010.  The recalled Propafenone HCL 225 mg Tablets were sold in 100 count bottles in the United States.  The affected lot of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall.

According to the Food & Drug Administration (FDA), Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot at the consumer level to minimize any potential risk to patients.

Patients using 225 mg Propafenone HCL tablets who have medical questions should contact their health-care provider.

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.

“Though rare, these are serious adverse events associated with the use of oral sodium phosphates—both prescription and over-the-counter products,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.  Woodcock added, “In some cases, these serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk for developing kidney injury.  We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products or they did not drink sufficient fluids after ingesting OSP products.”

The FDA warns that OSPs should never be used by children under 18 years of age or with other laxative products containing sodium phosphate and is recommending caution for bowel cleansing by people over 55 years of age; who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying; and people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (blood pressure lowering medications), angiotensin receptor blockers (for treatment of high blood pressure, heart, or kidney failure), and, possibly, nonsteroidal, anti-inflammatory drugs (such as ibuprofen and other arthritis medications).

In addition to the boxed warning, the FDA has also mandated that the OSP makers develop a risk evaluation and mitigation strategy (REMS), distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of OSPs, and conduct a post-marketing clinical trial to further assess the risk of acute kidney injury with OSP use.

The FDA said it was also concerned with the risks of using over-the-counter (OTC) OSP products such as Fleet Phospho-soda, when taken at higher doses for bowel cleansing.  Current information does not indicate a risk of acute kidney injury when OTC OSPs are used at lower, laxative-level doses; however, when used for bowel cleansing, the OTC OSPs present the same kidney risks as prescription strength OSPs.  Because of this and also because of ongoing reports of acute phosphate nephropathy, the FDA plans to update labeling for the OTC products.  The agency recommends consumers not use OTC OSPs for bowel cleansing.

Meanwhile, in response to the FDA warning, C.B. Fleet Company immediately announced a voluntary recall—directed to retailers and wholesalers—of its OTC products:  Fleet(R) Phospho-soda(R) and Fleet(R) Phospho-soda(R) EZ-Prep(R) Bowel Cleansing System.  Fleet will look to address the FDA decision to make these products available by prescription only.