A recall of Cleviprex injectable emulsion by The Medicines Company has been expanded. The recall, first announced last December, was issued due to the potential presence of visible particulate matter which has been observed in some vials.

According to the recall notice, the particulate matter observed in the Cleviprex injectable emulsion is comprised of sub-visible inert stainless steel particles of around 2.5 microns. Particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs. More Cleviprex Recall Expanded

Johnson & Johnson has outlined the steps it has taken to prevent a repeat of the musty-Tylenol debacle that occurred last year. Johnson & Johnson’s McNeil Consumer Health unit had been criticized by the Food & Drug Administration (FDA) for its handling of the incident.

The problems with musty Tylenol came to light in November, when McNeil recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP. The recall was issued after consumers complained of reports of a musty odor, which was associated with nausea, stomach pain, vomiting and diarrhea. More Smelly Tylenol Maker Responds to FDA Warning Letter

We have long been writing about a series of problems with K-V Pharmaceutical Company. In December, K-V Pharmaceutical said that the U.S. Food and Drug Administration (FDA) accepted its work plan to address the issues. Now, KV Pharmaceutical said it will be closing down its ETHEX generic drug unit, wrote The Associated Press (AP). The drug maker will also plead guilty to criminal charges that allege ETHEX neglected to appropriately advise regulators about significant manufacturing problems that posed dangers to consumers, wrote the AP.

Last March, we wrote that the U.S. Food and Drug Administration (FDA) announced that a Consent Decree of permanent injunction was filed enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers, from making and distributing adulterated and unapproved drugs. That move followed an extensive series of incidents regarding KV Pharmaceuticals and its subsidiaries. More KV Pleads Guilty, Agrees to Close ETHEX Generic Drug Plant

Johnson & Johnson is taking heat from federal regulators over its recent recall of Tylenol and other over-the-counter drugs. According to a report in the Los Angeles Times, the Food & Drug Administration (FDA) has sent Johnson & Johnson unit McNeil Consumer Healthcare a warning letter for taking too long to issue the recall.

In November, McNeil recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP because of reports of a musty odor, which was associated with nausea, stomach pain, vomiting and diarrhea. That recall was expanded in December to include all lots of the product. Last week, the list of recalled drugs was expanded yet again to include various lot of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. The expanded recall includes about 50 million bottles of the medications. More Smelly Tylenol Recall Delayed, FDA Charges

A recall of Tylenol Arthritis Pain Caplets has been expanded to include all available product lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP.

In November, Johnson & Johnson’s McNeil Consumer Healthcare unit recalled 5 lots of this Tylenol product because of reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. According to a notice posted on the Food & Drug Administration (FDA) Web site, the original recall is being expanded as a precautionary measure. More More Tylenol Arthritis Pain Caplets Recalled

For the second time this month, a swine flu vaccine is being recalled because it may lack potency. This latest recall involves 4.7 million doses of the MedImmune’s nasal spray vaccine.

According to MedImmune’s recall notice, 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. More More Swine Flu Vaccine Recalled

Safety 1st, Cosco, Eddie Bauer and Disney branded infant car seats are being recalled today by Dorel Juvenile Group Inc. because they pose a fall hazard when used as a carrier. According to the Consumer Products Safety Commission (CPSC), this recall involves 447,000 car seats/carriers sold with Travel Systems. The stroller portion of the travel system is not affected by this recall.

According to the recall notice, when used as an infant carrier, the child restraint handle to the car seat can loosen and come off, posing a fall hazard to infants. Dorel has received 77 reports of the child restraint handle fully or partially coming off the car seat/carrier resulting in at least three injuries to infants including bumps, bruises and a head injury. More Infant Car Seats Recalled for Fall Hazard

A batch of swine flu vaccine – also known as the H1N1 vaccine – has been recalled in Canada. According to the Associated Press, GlaxoSmithKline recalled the batch of H1N1 vaccine after receiving 6 reports of severe allergic reactions following administration of the swine flu shot.

The recall includes about 100,000 doses of the Glaxo swine flu vaccine, known as Arepanrix. In a written statement, Glaxo said it was issuing the recall because the Public Health Agency of Canada has received a higher than expected number of reports of anaphylaxis in this lot number compared to other lots. Generally, there should only be one or two such reactions in a batch of vaccine this size. The batch contained about 170,000 doses. More Glaxo Recalls Swine Flu Vaccine in Canada

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 Vicks Sinex Nasal Spray Recalled Over Bacterial Contamination

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 Pai You Guo Weight Loss Supplement Recalled