The FDA keeps consumers current with all food and drug recalls, voluntary and mandatory. It’s is important when tracking recalls to note the purpose of the recall and whether it is at wholesale, retail or consumer level. In some cases, the consumer may continue to use the product. In other cases, evidence of contamination has been found. Some products have undeclared allergens or have been mislabeled. Food and drug recalls of special interest for parents include the following:

* “Rushing Waters Fisheries, Palmyra, is recalling about 225 pounds of smoked trout and smoked salmon spreads, because the products may be contaminated with Listeria monocytogenes.” (FDA)

* Frontier Natural Products Co-op nutmeg (salmonella)

* McCormick and Company Golden Dipt Fry Easy All Purpose Batter (voluntary recall for unlabeled egg ingredient)

* Mylanta, AlternaGEL Liquid products, TYLENOL Cold Multi-Symptom liquid, Children’s BENADRYL Allergy FASTMELT Tablets and Junior Strength MOTRIN Caplets cherry and grape flavor, Rolaid’s Extra Strength Softchews (Wholesale and Retail recall; no action necessary for consumers, may continue to use)

* Whole Foods Markets and Bravo Farms Cheese (cheese products list here) Evidence of e.coli and Listeria. Also Del Bueno products.

* Krunchers! Jay’s Original Potato Chips (undeclared milk allergen)

* Costco, DPI Specialty Foods Mauri gorgonzola cheese (voluntary recall for possible e. coli contamination)

* Liz Lovely chocolate (undeclared dairy)

* Artisan Confections Dagoba new moon Rich Dark Chocolate (salmonella)

* Duro Extend Capsules for Men (marketed as dietary supplement, contains Sulfoaidenafil (used in treatment of Erectile Dysfunction)

Parents are urged to visit the FDA’s Holiday Food Safety Success Kit page for tips, resources and free printable activities about health and food safety. You’ll find recipes, games, tips and helps. There are free printable shopping lists, food labels, brochures, coloring pages and activity booklets for children. The Holiday Food Safety Videos emphasize the basics of safe food handling in any season, which can be remembered as CSCC:

Clean: Wash hands and surfaces often (use hot water)

Separate: Keep foods separate; don’t cross-contaminate

Cook: Cook to proper internal temperature

Chill: Refrigerate foods promptly.

A division of Johnson & Johnson is recalling 43 over-the-counter medicines made for infants and children — including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl — after federal regulators identified what they called deficiencies at the company’s manufacturing facility.

The voluntary recall, which was announced late Friday by McNeil Consumer Healthcare, affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the United States and its territories and in nine other countries — a vast portion of the children’s medicine market.

The Food and Drug Administration is advising parents and caregivers to stop using the affected products, although Commissioner Margaret A. Hamburg called the potential for serious health problems resulting from the medications “remote.”

FDA inspectors had begun a routine inspection April 19 in the company’s Fort Washington, Pa., plant when they noticed “manufacturing deficiencies” that triggered the recall, said Douglas Stearn, a senior FDA official.

Stearn said the plant’s manufacturing process was “not in control,” a term regulators use to describe flawed procedures that affect the composition of medicine. Federal investigators do not know when the problems at McNeil began, but Stearn said that “this does go back in time” and that “we have to try to figure that out.”

While the FDA investigates, McNeil has suspended operations at the facility. In a statement, the company said: “Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.” It said the problems may affect “purity, potency or quality.”

Marc Boston, a McNeil spokesman, would not discuss the deficiencies cited by the FDA or say when the manufacturing facility was shut down. The company also declined to disclose the amount of products affected by the recall. In addition to the United States, Puerto Rico and Guam, the medicines were sold in Canada; the Dominican Republic; Dubai, in the United Arab Emirates; Fiji; Guatemala; Jamaica; Panama; Trinidad and Tobago; and Kuwait.

A complete list of recalled products is on the company’s Web site.

McNeil received consumer complaints associated with some of the recalled medicines, but the company’s decision to pull them was not made on “the basis of adverse medical events,” said Boston, who declined to elaborate.

If a child who has taken any of the recalled medications exhibits any unexpected symptoms, parents or caregivers should contact a doctor, federal officials said. Consumers or health-care providers who experience problems connected to the recalled medicines are asked to contact the FDA.

As of Saturday, the FDA was not aware of any health problems related to the recalled products, said spokeswoman Elaine Gansz Bobo.

Parents and caregivers can use generic versions of the affected medicines; they are not affected by the recall. The FDA cautioned against giving adult versions to infants and children, noting the potential for serious problems.

This is at least the third major recall of Tylenol products by McNeil since 2008.

In January, McNeil recalled 49 types of Tylenol products made for adults and two Tylenol products made for children after consumers complained of a mold-like odor and of temporary and minor nausea, stomach pain, vomiting and diarrhea. The company determined that some of the medicines had been contaminated by trace amounts of a chemical that is sometimes present on shipping and storage material.

In 2008, McNeil recalled 21 types of children’s and infants’ Tylenol liquid products, saying that although the products met internal standards, an unused portion of one inactive ingredient did not meet all quality standards

Jan. 15, 2010—

A recall of Tylenol products that began last month with the popular Tylenol arthritis caplet expanded this morning to include more than two dozen other over-the-counter products manufactured by McNeil Healthcare LLC, the arm of Johnson & Johnson that manufactures Tylenol products.

The broadened directive adds 54 million bottles of product to the recall, boosting the total number of bottles recalled by McNeil to 60 million, according to the company.

McNeill initiated a voluntary recall of Tylenol Arthritis Relief Caplets at the end of December after consumer complaints of stomach problems. The problems were linked to the presence of a chemical called 2,4,6-tribromoanisole (TBA), which results from the breakdown of a chemical in wood pallets used to transport and store packaging materials for the drugs.

Now it appears that the problem extended into other Tylenol products as well, according to the U.S. Food and Drug Administration.

Tylenol Extra Strength, Rolaids and a number of children’s medicines are now included in the recall, which affects 27 products in various packaging quantities.

McNeil released a statement today in which it said the voluntary recall is being conducted in consultation with the FDA and affects a number of products for which there have been no complaints.

The company added that the musty-smelling chemical thought to be the cause of the sickness posed no fatal risk to those who ingest it.

“The health effects of this chemical have not been well studied, but no serious events have been documented in the medical literature,” the statement read.

“In addition to the product recall, McNeil Consumer Healthcare is continuing its investigation into the issue and is taking further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets.”

In its statement, the company advised consumers who purchased the affected products to stop using them and contact McNeil for information about how to get a refund or a replacement. The company provided the address for its Web site, www.mcneilproductrecall.com, as well as a toll-free number: (888) 222-6036.

Prior to today’s recall, the FDA had cited at least two of the company’s products in a letter to McNeil, as these products had been the subject of complaints about an “uncharacteristic smell,” similar to the one that helped trigger the recall of the arthritis caplets.

“Since the date of the discovery, your firm did not extend the assessment of the event to other products that received packaging components from the same supplier,” said the FDA’s letter, which was signed by Jose R. Lopez, an investigator, and Raquel Gonzalez Rivera, a chemist.

The letter goes on to cite over 10 “musty-moldy odor” complaints about Rolaids and over 39 similar complaints about Tylenol Extra Strength, “including three adverse event reports.”

The letter is dated Jan. 8, 2010, but was posted to the FDA’s Web site Jan. 13.

“Certainly, the FDA report raises serious questions about the manufacturer’s response,” said Robert Field, professor of health management and policy at the Drexel University School of Public Health. “The report has found that the investigation was limited…that the procedures for quality control were not in writing…and various other lapses that were fairly significant.”

The FDA report further criticized McNeil for inadequate responses to complaints, noting that they first received heightened complaints about the musty odor in 2008 and testing confirmed its presence in September of that year.

“Your quality unit failed to conduct additional testing to evaluate the possibility of chemical contamination or other change or deterioration in the distributed drug product,” the FDA letter says.

Current problems with Rolaids and Tylenol Extra Strength are attributed to another testing failure.

“Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy,” the report said.

In response to an inquiry from ABC News correspondent David Kerley, the company responded on Thursday:

“McNeil Consumer Healthcare has received an FDA form 483 dated Jan. 8, 2010, and is actively working with the FDA to address their concerns.”

Effects of Tainted Pills Not Deadly

One positive for consumers is that, as ABC News Senior Medical Editor Dr. Richard Besser noted in December, after the first recall was announced, the effects of the tainted pills were not life threatening.

“They’re not that severe, we’re talking about vomiting, diarrhea,” said Besser. However, he advised, “if you have this product, you should get rid of them, safely dispose of them in your trash. You don’t want them around.”

Field agreed, following news of the initial recall.

“It does not look like there were serious health effects, if any,” he said, “but why take a chance? These products are supposed to improve your health, not hurt it.”

Updated More Products

Johnson & Johnson issued a massive recall Friday of over-the-counter drugs including Tylenol, Motrin and St. Joseph’s aspirin because of a moldy smell that has made people sick.

It was the second such recall in less than a month because of the smell, which regulators said was first reported to McNeil in 2008. Federal regulators criticized the company, saying it didn’t respond to the complaints quickly enough, wasn’t thorough in how it handled the problem and didn’t inform the Food and Drug Administration quickly.

The recall includes some batches of regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin.

The FDA and Johnson & Johnson’s McNeil Consumer Healthcare Products said they did not know the number of bottles recalled. It included caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji.

Consumers should check the full list at http://www.mcneilproductrecall.com to identify the recalled batches.