Vicks Sinex nasal spray is being recalled in three countries because of potential bacterial contamination. According to a recall notice issued by Proctor & Gamble, the recall includes three lots of Vicks Sinex nasal spray sold in the United States, United Kingdom and Germany. The bacteria, B. cepacia, has been found in a small amount of Vicks Sinex nasal spray from the recalled lot sold in the States, the notice said.

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

(more…)

The U.S. Food and Drug Administration (FDA) informed GMP Herbal Products, Inc. that its weight loss dietary supplement, sold and marketed as Pai You Guo, contains undeclared ingredients.

An FDA lab analyses of dietary supplements distributed by GMP Herbal Products found them to contain two undeclared ingredients: (more…)

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30%, as well as 73 lots of Propofol Injectable Emulsion 1% products that begin with lot numbers 79 and 80. The recall has been implemented, said the U.S. Food and Drug Administration (FDA), because some of the containers may contain particulate matter.

The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall. (more…)

This year, the U.S. Food and Drug Administration (FDA) mandated Bayer—maker of the birth control pill, Yaz—to run a correction to its Yaz marketing that cost some $20-million. Bayer must also submit its ads to the agency for approval resulting from a legal settlement obtained by some state attorneys general and the agency.

Now, Yaz and Yasmin lawsuits originating in New Jersey might be deemed a mass tort. According to Law.com, a Passaic County request is being considered by the judiciary in that state for the mass tort status. (more…)

American Regent is recalling more Ketorolac Tromethamine Injection. The company is now expanding its recall of the injectable painkiller to include all lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials; NDC# 0517-0601-25.

According to the Food & Drug Administration (FDA), this recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. The recalled drug product was distributed to wholesalers and distributors nationwide. (more…)

Bodybuilding.com has issued a nationwide recall for 65 dietary supplement products. All of the recalled supplements were sold through the Bodybuilding.com Web site. According to a notice on the Food & Drug Administration (FDA) website, the agency believes the recalled products contain ingredients that are steroids.

A list of the recalled dietary supplements can be accessed here. The recall includes all lots and expiration dates of the dietary supplement products listed. (more…)

Children’s and Infants’ Tylenol liquid medicines have been recalled because of possible bacterial contamination. The recall involves more than 20 Children’s and Infants’ Tylenol liquid varieties.

According to a “Dear Healthcare Professional” letter issued by McNeil Consumer Healthcare, the bacteria Burkholderia cepacia (B. cepacia) was detected in an “inactive ingredient” in products manufactured between April and June 2008. While ingestion of contaminated pharmaceutical product is not known to be a route of transmission of B. cepacia infection, infection has been reported following the use of contaminated pharmaceutical products such as mouthwashes and nasal sprays. Adverse health consequence of B. cepacia infections could be potentially severe especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis or compromised immune systems. (more…)

The U.S. Consumer Product Safety Commission (CPSC), in an effort to create a permanent oversees presence, is planning on opening an office in Beijing. The office is being set up, in part, reported HeraldTribune.com to better work with both Chinese regulators and companies in China and ensure exports coming into the United States from China are safe, according to agency chairwoman Inez Tenenbaum.

The move follows an unprecedented number of recalls that have involved consumer products, children’s toys, pet food, fish, dairy products, and toothpaste, to name just some, noted HeraldTribune.com. Compounding the issue, in recent months toxic Chinese drywall has been causing illness and raising alarm with residents nationwide. (more…)

Arthritis and other autoimmune medications have made recent headlines over a variety of issues including links to serious opportunistic fungal infections and cancer. Now, as part of President Barack Obama’s health care overhaul, a review of arthritis medications manufactured by Wyeth, Abbott Laboratories, and Johnson & Johnson (J&J) might warrant some additional scrutiny, reports Bloomberg.com.

Recently, we reported that federal regulators ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The U.S. Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of its Amendments Act of 2007. (more…)

Zicam maker Matrixx Initiatives Inc. said that it has received an informal inquiry from the Securities Exchange Commission (SEC) over last week’s Food & Drug Administration (FDA) warning on several Zicam nasal cold remedies. Matrixx shares plummeted a whopping 70% the day of the FDA warning.

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. (more…)