Children's liquid cold, allergy medicine recalled

[Jolie Rouge]

Children's liquid cold, allergy medicine recalled
56 mins ago

WASHINGTON – More than 40 over-the-counter infant's and children's liquid medications are being recalled in the United States and 11 other countries because they don't meet quality standards.

McNeil Consumer Healthcare issued the recall for children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl after consulting with the Food and Drug Administration.

The company is recalling the products because some did not meet required quality standards, the company said in a statement Friday. Some of the products recalled may have a higher concentration of active ingredient than is specified on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements.

The company is advising consumers to stop giving the products to their children as a precautionary measure. The recall was not undertaken because of any adverse effects, the company said.

The medicines were made and distributed in the United States, and exported to Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago and Kuwait.

Details, including NDC numbers, are available by telephone at 1-888-222-6036 or on the Web at http://www.mcneilproductrecall.com.

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On the Net: McNeil Product Recall Information: http://www.mcneilproductrecall.com

Food and Drug Administration: http://www.fda.gov/medwatch



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[jasmine]

thanks!

[Jolie Rouge]

FDA investigating recall of children's medicine
Sat May 1, 12:11 pm ET

WASHINGTON – The Food and Drug Administration said Saturday it was investigating a health-care company for possible other problems following its recall of more than 40 over-the-counter infant's and children's liquid medications.

McNeil Consumer Healthcare, based in Fort Washington, Pa., issued the voluntary recall late Friday in the United States and 11 other countries after consulting with the FDA. The recall involves children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl, because they don't meet quality standards.

The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems. "We are following through with the facility to make certain that everything has been checked," said FDA spokeswoman Elaine Gansz Bobo.

According to McNeil and the FDA, some of the products recalled may have a higher concentration of active ingredient than is specified on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements.

The FDA called the potential for serious medical problems "remote," but it advised consumers to stop using the medicine as a precaution. It said a health care professional should be consulted if a child has recently taken any of the recalled products and is exhibiting unexpected symptoms.

The FDA also says parents in the interim should consider substitute child medications, such as generic versions. It does not recommend that children be given adult-strength Tylenol or Motrin because they are not intended for younger age groups.

The medicines were made and distributed in the United States, and exported to Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago and Kuwait.

Details are available by telephone at 1-888-222-6036 or on the Web at http://www.mcneilproductrecall.com.


http://news.yahoo.com/s/ap/20100501/ap_on_he_me/us_children_s_medicine_recall;_ylt=AvLNOHiLDrESm2k 2UKeiF5is0NUE;_ylu=X3oDMTFkYzE0ZXR0BHBvcwMxNDcEc2V jA2FjY29yZGlvbl9oZWFsdGgEc2xrA2ZkYWludmVzdGlnYQ--

[magickay]

Thanks - shared the info with my Facebook friends

[Jolie Rouge]

Product Coupon/Refund Request

To receive a coupon good for future purchase or a refund for product affected by the recall, please complete this form in full with the required information. A representative from our Consumer Care Center may call you to verify your information.

If you have more than 6 affected products, please complete a second form with the remaining products or call the Consumer Care Center at 1-888-222-6036 We understand that this may cause some inconvenience at this time and appreciate your patience. Our Consumer Care Center is available Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time.

https://www.mcneilproductrecall.com/page.jhtml?id=/include/replacement_coupon.inc

[Jolie Rouge]

FDA issues "stop using" alert on certainover the counter Tylenol, Motrin, Zyrtec, and Benadryl products Details and FDA what to do ... http://www.emergencyemail.org/newsemergency/anmviewer.asp?a=503&z=43

Risk news rating: Severe

FDA provides consumer advice following recall of products for infants and children

FDA recommends that consumers stop using these products.

List of products
The products include certain liquid infant's and children's Tylenol, Motrin, Zyrtec, and Benadryl products. For a complete list of recalled products, please see the recall notice and list of products1.

Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children?s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Following McNeil?s recall announcement on Friday evening, the FDA is providing additional advice to consumers.

"We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more."

What products are affected by this recall?

The products include certain liquid infant?s and children?s Tylenol, Motrin, Zyrtec, and Benadryl products. For a complete list of recalled products, please see the recall notice and list of products1.

Why were these products recalled?

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use.

What can I use instead of the recalled products?

There are a number of other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. FDA recommends that you check the labeling of these products. If you have any questions, you should discuss this with your pharmacist or other health care professional. FDA does not anticipate that there will be a shortage of alternative products.

Can I give my child adult strength Tylenol or Motrin products that are not being recalled?

No. Consumers should not give drug products to infants and children that are not intended for those age groups. This could result in serious harm.

What should I do if I have some of the medication at home?

FDA recommends that consumers stop using these products.
For further instructions, see McNeil?s website at: www.mcneilproductrecall

I gave my child some of the medication. What do I do? Is my child at risk?

According to the information the FDA has received at this time, the potential for serious medical problems is remote. If your child exhibits any unexpected symptoms after use of any of the recalled products, contact your health care professional.

If I think my child may be having an adverse reaction to one of the products involved in this recall, who should I notify?

Adverse reactions or quality problems experienced with the use of these products may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax, using the contact information at the bottom of this sheet. The agency asks health care professionals and consumers to report any adverse reactions to the FDA?s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch3.

[Jolie Rouge]

FDA found bacteria in lots for recalled Tylenol
By Matthew Perrone, Ap Business Writer Tue May 4, 6:30 pm ET

WASHINGTON – Ingredients used by Johnson & Johnson in some of the 40 varieties of children's cold medicines recalled last week were contaminated with bacteria, according to a report by the Food and Drug Administration.

Agency officials said Tuesday none of the company's finished products tested positive for the contaminants, though such testing is not definitive.

"We think the risk to consumers at this point is remote," said Deborah Autor, director of FDA's drug compliance office, on a call with reporters.

The FDA report, which was posted online, lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort Washington, Pa., where the formulas were made. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl.

FDA inspectors visited the plant in mid-April and wrapped up their inspection Friday. J&J issued its "voluntary" recall later that night.

Among other problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints.

J&J did not investigate more than 46 complaints received in the last year about "black or dark specks" in Tylenol products, according to the FDA's report.

Additionally, inspectors found some pieces of equipment covered with thick layers of dust, while others were held together with duct tape.

In a statement Tuesday, J&J called the problems cited by the FDA "unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate." The health conglomerate, which is based in New Brunswick, N.J., said production at the plant won't resume until the problems have been fixed.

The FDA reiterated that serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution. Parents are instructed to use generic alternatives instead.

J&J's McNeil Consumer Healthcare unit has said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet testing requirements.

FDA leadership told reporters Tuesday that they first met with J&J in February to discuss manufacturing problems identified in a warning letter about another J&J plant. The agency decided to step up inspections of the company's facilities based on those problems.

"That warning letter brought us to the point where we thought it was necessary to sit down with management and discuss our concerns," Autor said.

FDA officials said they are considering taking additional action against J&J, ranging from issuing more warning letters to pursuing criminal action.

Last week's sweeping recall, which involved products sold in the U.S. and 11 other countries, is the latest quality issue to taint J&J's over-the-counter medicine franchise. In January, the company recalled a line of adult Tylenol pain relievers due to complaints of a moldy smell associated with wooden pallets used to transport the drugs.

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[jasmine]

am I wrong, but doesn't it seem like you never hear of generics being recalled


I use alot of store/generic brands

[Jolie Rouge]

FDA probing hundreds of complaints with J&J meds
By Matthew Perrone, Ap Business Writer 50 mins ago

WASHINGTON – Federal health regulators are investigating hundreds of consumer complaints involving children's medicines recalled by Johnson & Johnson last month, according to a congressional memo.

The Food and Drug Administration has not directly linked any of the reports to flaws with the company's products.

J&J recalled more than 40 varieties of children's cold medicines last month after FDA inspectors discovered a slew of manufacturing problems at a Pennsylvania facility. The company's third recall in the past year triggered a flurry of criticism from Washington lawmakers, who will question company management at a hearing Thursday.

A spokeswoman for J&J declined Wednesday to comment on the congressional memo. Late Tuesday the company posted a statement on its Web site saying it would restore its public image by restructuring management and overhauling manufacturing operations.

"McNeil is taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies, and that the public rightly expects of us," read the statement.

Since the April 30 recall, the FDA has received hundreds of reports of complications with J&J products, including seven deaths, according to a memo distributed to congressional staffers. The memo was obtained Wednesday by the Associated Press.

FDA is investigating whether the problems are linked to flaws in J&J products, which include infant Tylenol, Benadryl and Motrin.

"At this time, FDA is not aware of any child being harmed by taking one of the recalled products," states the congressional memo.

FDA deputy commissioner Joshua Sharfstein is scheduled to testify. Sharfstein is expected to provide new detail on problems uncovered at J&J's Fort Washington, Penn. plant.

FDA inspectors found that J&J failed to investigate medications that had potentially unsafe potency levels, according to FDA documents cited in the memo. While J&J rejected three batches of Infant Tylenol found to be overly potent, the company failed to check seven other batches at risk for the problem.

In another instance, FDA found that J&J did not recall a batch of products potentially infected with bacteria. The products were in distribution last fall and could still be on store shelves, according to FDA.

Colleen Goggins, J&J's president for McNeil consumer products, will testify before the House Committee on Oversight and Government on J&J's handling of the recall.

J&J, which is based in New Brunswick, N.J., has long enjoyed a sterling public image, even taking first place last year in a poll of corporate reputations.

That positive image is due in part to J&J's handling of past product recalls.

The company's response to a 1982 cyanide tampering scare in Chicago that killed seven people is considered a textbook example of how to deal with a brand crisis. J&J had its sales force remove 264,000 Tylenol bottles from store shelves and consumers were urged to return any Tylenol they had for a safe bottle.

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