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According To FDA Report, J&J Plant Still Has Quality Control Issues

According To FDA Report, J&J Plant Still Has Quality Control Issues

According to a Daily Finance news story released yesterday, regulators revealed that Johnson & Johnson “still hasn’t solved all the problems at the Pennsylvania plant largely responsible for a huge recall of children’s medicine earlier this year.”

The article goes on to explain that “More than 135 million bottles of different over-the-counter medicines were recalled in late April because of manufacturing deficiencies at J&J’s McNeil Consumer Healthcare Unit plant in Fort Washington, Pa.” According to the article, this most recent Food and Drug Administration inspection revealed “horrific conditions and processes, including such findings as grime, dust, a hole in the ceiling and bacteria-contaminated raw ingredients.”

The article goes on to explain that since April, plant operations have been suspended as “J&J conducted a full review of its manufacturing processes.” However, the Daily Finance reports that “according to FDA investigators, a recent inspection conducted from Oct. 27 through Dec. 9 still revealed problems, most notably, a failure to properly follow customer complaints.”

According to the article, a recent inspection report released by the FDA found numerous additional problems with the plant. The Daily Finance reports these include such procedural issues as failure to establish “Control procedures that monitor the output and validate the performance of the manufacturing processes,” “failure to thoroughly review any unexplained discrepancy and failure of a batch or any of its components,” as well as a lack of record keeping to “allow data to be reviewed at least annually to evaluate the quality standards.”

The news source further reports “a discrepancy and a failure of a batch or any of its components 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.” Finally, the article reports the FDA found that the company failed to always make records of “unexplained discrepancies” and didn’t always follow “responsibilities and procedures applicable to the quality control.” 

The news source states that since the initial April recall, J&J has “issued many other recalls, some resulting from its review process, but not all.” The Daily Finance explains that a Puerto Rico plant “also tied to the drug recalls reportedly still has quality control problems as well.” The Daily Finance claims that additional recalls “are likely as the review process continues.”

If you or a loved one has experienced serious side effects or health complications with a Johnson & Johnson product, contact Newsome Law Firm  and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with hazardous medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.

References:

Alazraki, Melly. (December 16, 2010) “FDA Finds More Problems at Johnson & Johnson Plant.” Retrieved on December 17, 2010 from Daily Finance.
 

J&J Hip Replacement Lawsuits Consolidated, Will Be Seen By One Judge

J&J Hip Replacement Lawsuits Consolidated, Will Be Seen By One Judge

According to Bloomberg News, a judicial panel recently decided that all of the pretrial proceedings in federal lawsuits against pharmaceutical giant, Johnson & Johnson, over their recalled hip-replacement systems will be overseen in Ohio by one federal judge.

The news source reports that U.S. District Judge David A. Katz will “supervise evidence-gathering efforts in cases over the ASR XL Acetabular System, which J&J’s DePuy Orthopaedics unit recalled on Aug. 26 after the implants stopped functioning properly.”

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Recall Woes Deepen For Johnson & Johnson

Recall Woes Deepen For Johnson & Johnson

MSNBC news reports that things worsened on Wednesday for the pharmaceutical giant, Johnson & Johnson, after they recalled 12 million bottles of their over-the-counter medicine, Mylanta, and nearly 85,000 bottles of AlternaGel liquid antacid.

The news source explains the company initiated the recalls because “the presence of small amounts of alcohol from flavoring agents was not noted on product packaging.”

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Johnson & Johnson-Funded Surgeons Warn Patients About Hip Implants

Johnson & Johnson-Funded Surgeons Warn Patients About Hip Implants

DePuy Orthopedics issued a recall of their ASR Acetabular hip replacement device and one other device in August of 2010. A 24-7 Press Release article quoted in full on the Medical Quack web site reveals that DePuy sent a packet to orthopedic surgeons two days before making the recall public. The packet announced the upcoming recall and instructed surgeons to pass along a medical release form to patients with the recalled device implanted.

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Depuy ASR Hip Recall Symptomatic of Deeper Issues

Depuy ASR Hip Recall Symptomatic of Deeper Issues

The August 2010 voluntary Depuy ASR Recall and subsequent Depuy Hip Class Action Lawsuit cases have revealed more problems than patients might suspect. Johnson & Johnson seems to be facing a never ending onslaught of product recalls, factory closures, lawsuits, and media scrutiny over quality control in multiple divisions.

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Johnson & Johnson Under Scrutiny For Alleged Misinformation

Johnson & Johnson Under Scrutiny For Alleged Misinformation

The recent recall of some pediatric medications, Tylenol, Motrin, Benadryl and Zyrtec, manufactured by Johnson & Johnson, prompted a Congressional investigation. A unit of Johnson & Johnson, McNeil Consumer Healthcare, is the company that actually manufacturers these over-the-counter drugs. The company is being scrutinized by the Food and Drug Administration for violations in the manufacturing of a number of drugs.

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Levaquin makers Johnson & Johnson under fire for potential kickbacks

Levaquin makers Johnson & Johnson under fire for potential kickbacks

Pharmaceutical giant Johnson & Johnson is under investigation by the U.S. Justice Department amid allegations that the company paid millions in dollars in kickbacks to Omnicare, one of the largest pharmacies in the U.S. According to accusations, Johnson & Johnson paid Omnicare, which specializes in nursing home care, to use its influence over physicians to prescribe drugs like Risperdal and Levaquin in lieu of competitive drugs.

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Tylenol Recall is second in one month for Johnson & Johnson

Tylenol Recall is second in one month for Johnson & Johnson

Johnson & Johnson’s McNeil Consumer Healthcare has recently issued a large voluntary recall of the company’s widely popular over-the-counter drugs Tylenol, Motrin, and Benadryl, among others. The recall is due to an inexplicable mold smell that has been causing illness among consumers. This is the second time in one month that McNeil has recalled these products due to the same smell problem. The recall affects McNeil products sold in the U.S., Canada, Mexico, Fiji, most Central and South American countries, and the United Arab Emirates.

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