FDA investigates 775 'adverse events' from Tylenol recall - May ...
May 25, 2010 ... "We track all adverse events and thoroughly investigate all serious adverse cases that are reported and, in turn, report these to the FDA, ...
Daily Kos: FDA investigating raft of complaints about Tylenol ...
May 26, 2010 ... Now we know what the FDA is looking into--at least 775 customer complaints ..... A serious adverse event (SAE) is one that results in Death, ...
www.dailykos.com/.../-FDA-investigating-raft-of-complaints-about-Tylenol-makers-products -
FDA Evaluating 775 Side Effect Reports from Children's OTC Drugs
May 26, 2010 ... FDA Evaluating 775 Side
Effect Reports from Children's OTC Drugs ... track all adverse events and thoroughly investigate all serious adverse ...
www.americas-watchdog.com/fda-evaluating-775-side-effect-reports-from-childrens-otc-drugs/ -
GAO-01-775T Human Subjects Research: HHS Takes Steps to Strengthen ...
File Format: PDF/Adobe Acrobat - Quick View
GAO-01-775T adopted a separate set of human subjects protection ..... regarding reporting of serious adverse events that are different from FDA's ...
korvas-sux.appspot.com/www.gao.gov/new.items/d01775t.pdf
Searches related to 775 serious adverse events
The company voluntary recalled 43 over-the-counter medicines, including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl, because of "manufacturing deficiencies which may affect quality, purity or potency," according to the FDA. Those "manufacturing deficiencies" included myriad manufacturing process, control and procedure issues, such as inadequate laboratory facilities and untrained staff, as well as grime, dust, a hole in the ceiling, clutter and bacteria-contaminated raw ingredients in the Fort Washington, Penn., plant. One pharmaceutical professor described the conditions as "shocking,"CNN reported.
'Unacceptable' Results
Still, Johnson & Johnson itself called the manufacturing problems "unacceptable," apologized and promised to fix them. And after eight months and five recalls, the company earlier this month suspended production at the plant. Critics contend that with so many recalls, it's difficult to see how the company failed to discover the issues earlier. And the FDA, finally realizing that the problems could be more widespread, on Monday said it would expand its investigation of McNeil's drug-manufacturing practices "to determine whether similar problems exist throughout the company."
So far, Johnson & Johnson's reputation doesn't seem to be faring as well in this recall as it did in 1982. Some industry watchers have accused Weldon of being completely out of touch with consumers, while others found his short apology on the company blog-- as well as other apologies in media interviews-- insufficient.
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By Matthew Perrone, Associated Press WASHINGTON — Ingredients used by Johnson & Johnson (JNJ) in some of the 40 varieties of children's cold medicines recalled last Friday 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 exhaustive. "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 lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort Washington, Pa., where the formulas were produced. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl... |
