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zoom RSS 小児用市販解熱剤タイレノールのリコール/米国医療事情 FDA 品質管理に多くの問題

<<   作成日時 : 2010/05/06 19:05   >>

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画像 Johnson & Johnsonは、市販の子供用水薬のリコールを始めたとFDAが土曜日(5/01)に公表した。効力・純度・質に影響する可能性があり、同じ工場で製造された他の製品も問題ないか調査中という。
 乳幼児用のタイレノール、モトリン、ジルテック、ベナドリルなどの使用を中止するようにと発表された。
 ペンシルベニアのフォート・ワシントンにある社内設備で定期検査で見つかった製造違反を連邦FDAが金曜日(4/30)の朝に発表した。
 今年1月のプエルトリコ工場で製造された市販薬のリコールに続き2度目のリコールとなる。
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 火曜日(05/04)の連邦FDA当局の検査報告によれば、先週末にタイレノールやモトリンなどの子供用市販解熱鎮痛薬のリコールをおこなったJohnson & Johnsonの一部門McNeil Consumer Healthcareには、多くの広範囲な品質管理問題がみつかったという。
 McNeil Consumer Healthcareは、ペンシルベニア州フォート・ワシントンの工場で薬品製造課程での多数の問題を適切に修正できていなかった。細菌汚染された材料を使用していたが、幸い最終製品での検査では細菌検査は陰性であり消費者へのリスクは小さかったという。数十の消費者からの製品異物混入のクレームに適切に対応できていなかった。会社は該当工場での生産を中止し、是正措置で製品品質が確実にならない限りは製造再開しないと表明した。
 昨年9月以来、マクニール製品のリコールは5度目になる。
 1月にプエルトリコ工場の製品を大規模リコールした。2月にFDAはマクニールの製造工程について重大な懸念を表明していた。
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解熱鎮痛薬タイレノールの汚染問題、リコール対象拡大・回収遅延/米国医療事情 FDA
http://kurie.at.webry.info/201001/article_19.html
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Children’s Tylenol and Other Drugs Recalled
By NATASHA SINGER
Published: May 1, 2010
http://www.nytimes.com/2010/05/02/business/02drug.html

A unit of Johnson & Johnson has voluntarily begun a recall of certain children’s over-the-counter liquid medicines because of manufacturing deficiencies, the Food and Drug Administration said on Saturday.

The deficiencies may affect the potency, purity or quality of the products, the agency said in a statement. It said it was investigating the plant where the products were made to make sure there were no other problems.

Consumers should stop using certain lots of infants’ and children’s Tylenol, Motrin, Zyrtec and Benadryl products because some of them may contain more of the active drug ingredient than specified, the Johnson & Johnson unit, McNeil Consumer Healthcare, said in a statement late Friday. Other products involved in the recall may contain foreign particles or inactive ingredients that may not meet testing requirements, the company said.

“The particles may be solidified product ingredients or manufacturing residue such as tiny metal specks,” Marc Boston, a McNeil spokesman, said.

McNeil did not undertake the recall because of adverse health reactions to the products, the company said, but it advised consumers to stop using them.

Although the potential for serious medical problems is remote, McNeil said, parents and caregivers should not give the products to children.

The recall involves all unexpired lots of seven products in 43 different flavors and sizes. These include Tylenol Infants’ Drops, Children’s Tylenol Suspensions, Infants’ Motrin Drops, Children’s Zyrtec liquids in bottles and Children’s Benadryl Allergy liquids.

McNeil has posted a full list of the recalled product lots on a dedicated Web site: mcneilproductrecall.com. The recall comes after federal health regulators cited McNeil on Friday morning for manufacturing violations found during a routine inspection at a company facility in Fort Washington, Pa., an F.D.A. spokeswoman said. This is the second major recall this year for McNeil. In January, after receiving reports of moldy smells emanating from over-the-counter medicines made at a plant in Puerto Rico, the company recalled several hundred lots of adult and children’s products. The earlier recall involved certain lots of Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.

McNeil has a hotline, (888) 222-6036, available 8 a.m. to 10 p.m. Eastern time, Monday through Friday and on weekends from 9 a.m. to 5 p.m. But due to high call volumes, a reporter who called the hotline at different times on Saturday was unable to reach a customer service representative. A recorded message directed callers to the company’s Web site and later disconnected. McNeil said it was working to respond to the high call volumes.

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Agency Told Tylenol Maker of Many Quality Concerns
By NATASHA SINGER
Published: May 4, 2010
http://www.nytimes.com/2010/05/05/business/05tylenol.html

The Johnson & Johnson unit that voluntarily recalled certain lots of children’s liquid Tylenol and Motrin over the weekend had numerous and wide-ranging quality control problems at the plant that made the products, according to a federal inspection report released Tuesday.

That unit, McNeil Consumer Healthcare, failed to adequately investigate and correct various deficiencies in its manufacturing and drugs made at its plant in Fort Washington, Pa., according to the report, posted Tuesday afternoon on the Web site of the Food and Drug Administration.

“This is yet another example of the need for companies to take full accountability for the quality of their drugs, and the serious consequences that can happen when companies do not do so,” Deborah M. Autor, the director for compliance at the agency’s Center for Drug Evaluation and Research, said Tuesday during a conference call with reporters.

The report, which the agency had sent to McNeil last Friday, before the recall, said the company had used raw materials with known bacterial contamination to make certain lots of infants’ and children’s liquid Tylenol.

Samples of finished products tested negative for bacteria, however, and the risk to consumers was remote, agency officials said.

A McNeil spokeswoman disagreed with the F.D.A.’s account of the bacteria issue. She wrote in an e-mail message that that the company had not used material that had tested positive for bacteria. She said that a supplier had rejected some drums of a material from a master lot after finding bacterial contamination. But the drums sent to McNeil’s plant had tested negative for bacteria.

The F.D.A. report also said McNeil had not responded properly to several dozen consumer complaints about foreign particles found in certain medications.

McNeil said in a statement Tuesday that the company had temporarily stopped production at the Fort Washington plant. The company will not start manufacturing again until it has taken corrective actions and can assure the quality of products made there, the statement said.

The F.D.A. report concerns manufacturing deficiencies observed by federal health investigators during a routine inspection of the plant in April.

After receiving the report last Friday morning, McNeil late that evening recalled a wide range of certain lots of liquid infant’s and children’s Tylenol, Motrin, Benadryl and Zyrtec.

Some of these over-the-counter medicines may contain more of the active ingredient than is specified on the product label or tiny metal particles or inactive ingredients that do not meet testing standards, the company said. Although the possibility of health problems was remote, people should stop using the products, the company said.

A full list of the products can be found on the company’s Web site mcneilproductrecall.com.

Consumers can also call the McNeil recall hot line at 888-222-6036 for more information about a refund or coupon to replace the recalled products.

McNeil is not disclosing the overall number of bottles involved in the recall, a company spokesman said. The F.D.A. said Tuesday that the recall involved about 1,500 product lots.

This is the fifth recall of McNeil products since last September.

In January, for example, McNeil undertook a large-scale recall of certain lots of Tylenol, Motrin, Benadryl, Rolaids and St. Joseph Aspirin after consumer complaints about moldy smells emanating from certain products. The company said that the odor had been caused by a byproduct of a chemical used to treat wooden transport pallets that had leached into the products at a company plant in Puerto Rico.

In February, F.D.A. officials met with managers from McNeil and Johnson & Johnson to express serious concerns about McNeil’s manufacturing operations, the agency said Tuesday.

Since that meeting, McNeil has taken steps to improve its manufacturing processes, but F.D.A. officials said they had not yet determined whether the changes were sufficient or whether the agency would take further action against the company.

At the time of the January recall, industry analysts described the moldy smell problem at the Puerto Rico plant as a fluke and an isolated incident.

But some of the inspectors’ observations about the Fort Washington plant resemble problems the agency cited at the Puerto Rico plant. These include failure to follow certain good manufacturing standards and failure to adequately investigate consumer complaints.

McNeil said it was working with the agency to resolve the matter.

“The quality issues that the F.D.A. has observed, many of which we had recently identified in our own quality reviews and communicated to the F.D.A., are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate,” the McNeil statement said.

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