Children's TYLENOL Recall

Children's Tylenol Recall

Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.

The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

FOR IMMEDIATE RELEASE - April 30, 2010 – Fort Washington, PA. McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW).

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, 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 is specified; others may 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, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.
Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com1. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm

For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com 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). Any adverse reactions may also be reported 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/medwatch2.|

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.

FDA Widens McNeil Recall Investigation

No Positive Links Made To 7 Reported Deaths

J&J Failed to Address Issues

Not only that, but J&J failed to share some of the issues and investigation results with the FDA. The agency expressed its concerns to the company, which weren't always addressed. It said in its January 2010 warning letter to J&J that "Neither upper management at J&J nor at McNeil Consumer Healthcare assured timely investigation and resolution of these issues."

When the FDA finally inspected the plant in April 2010, it found that McNeil didn't properly test its products, didn't properly train its employees, failed to maintain equipment and lacked other important quality controls. The FDA also found that McNeil failed to sufficiently investigate problems in its manufacturing and drugs. The most alarming findings were that McNeil products had the potential to be super potent, and to be contaminated with bacteria and particulate matter.

There may be questions about FDA conduct as well. The agency has known about the problem at least since last September, and the Committee will want to hear what steps it took once it found out the products were contaminated, the Committee spokesperson said.

Deaths and Other Adverse Events

According to the FDA, 775 adverse events were reported for the recalled products, including 30 deaths, from Jan. 1, 2008, through April 30, 2010 -- and there have been several hundred additional adverse events, including seven deaths, since then. None of that shows a spike or a pattern, the FDA says.

The Chairman and other members of the committee have gone through internal documents of J&J and the FDA and will no doubt grill the witnesses. Meanwhile, Senator Tom Harkin (D-Iowa), chairman of the U.S. Senate's health committee, sent a letter to the FDA late Monday, asking the agency's commissioner for more information on the nationwide recall.

See full article from DailyFinance: http://srph.it/d0ah27

Children's Over-The-Counter Drugs

When a pharmaceutical company scrutinizes adverse effects, this means there have been complaints of serious drug side effects from death, disability, hospitalization, to other critical health concerns.

Stemming from an April 30 recall of dozens of children’s OTC drugs, in May, the FDA released a 17 page unfavorable report that detailed quality control issues and other problems at a Fort Washington, PA., manufacturing plant. Soon after, the facility closed.

On May 18, 2010 CNN Money wrote the FDA was expanding their McNeil investigation and May 25, Reuters said that Iowa Senator Tom Harkin recently had sent a letter to the FDA requesting more information.

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