Entries in McNeil (6)


FDA Slaps J&J for Tampon, KY Trouble

Cristina Arias/Getty Images(SKILLMAN, N.J.) -- The beleaguered consumer product giant Johnson & Johnson has had its hand slapped again by the FDA, this time for problems with tampons and other popular personal care products.

In a warning letter released Wednesday, the FDA admonished J&J’s McNeil unit for failing to adequately follow up on a range of consumer complaints. The most serious of the complaints includes a report of a woman who suffered from toxic shock syndrome after using an O.B. tampon.

McNeil’s plant in Skillman, N.J., manufactures a variety of personal care products, including O.B. tampons, Carefree and Stayfree menstrual napkins, KY brand lubricant and moisturizing products, as well as Reach dental floss.

In the reported case of toxic shock syndrome, J&J waited more than a month before alerting the FDA. And in a separate incident, J&J failed to tell the FDA that a consumer had lost a tooth while using Reach floss.

But the latest and most extensive list of offenses involved KY Liquibeads Vaginal Moisturizer. J&J markets Liquibeads as an “ovule insert”  that contains a “premium quality silicone formula” that “dissolves within minutes, locking in your body’s natural moisture and keeping intimate skin hydrated while enhancing comfort.”

For 227 consumers, who complained to J&J between June 2010 and December 2011, the Liquibeads did not live up to those promises of “enhanced comfort” or “more enjoyable” intimacy. Yet the company filed away such complaints -- under headings like “does not dissolve,” “uncharacteristic consistency/texture and “does not perform as expected.” The complaints were not, the FDA said, “adequately evaluated or investigated.”

The agency’s warning letter also raised questions about whether Liquibeads should be on the market at all, given the manufacturer’s failure to prove that the moisturizer is compatible for use with latex condoms.

J&J has until early June to outline a plan to correct the problems.

“We take the issues raised by the FDA seriously,” McNeill PPC, Inc. said in a statement to ABC News. “We will respond fully to their concerns and take whatever steps are needed to resolve these issues.”

This chiding from the FDA is only the latest in a string of problems that has plagued J&J in recent years. In 2010, metal and wood particles were found in 13 million packages of Rolaids. In 2011, J&J’s Ethicon was sued by more than 100 women citing negligence and defective product design of the vaginal mesh, Gynecare Prolift. And in March, J&J recalled, yet again, thousands of bottles of Tylenol 8 Hour Extended Release Caplets.

Copyright 2012 ABC News Radio


Batches of Motrin Products Recalled Over Dissolving Issue

Charles D Winters/Photo Researchers/Getty Images(FORT WASHINGTON, Pa.) -- McNeil Consumer Healthcare Division announced Wednesday it is recalling batches of three of its Motrin products, citing problems with how the drugs dissolve.

The voluntary recall affects certain lots of Motrin IB 24-count coated caplets, Motrin IB 24-count coated tablets and Motrin IB 24+6 count coated caplets.  After testing product samples, the drugmaker found that "some caplets may not dissolve as quickly as intended when nearing their expiration date."

[Click here to see the full list of affected Motrin products]

McNeil notes that the affected products do not pose a safety concern for consumers -- those who continue taking the drugs may just experience a delay in relief.

The drugmaker says it is recalling the products "out of an abundance of caution," and that "consumers do not need to dispose of or return the product."

Copyright 2011 ABC News Radio


New Dosing Instructions for Tylenol Products

Brendan Smialowski/Getty Images(FORT WASHINGTON, Pa.) – McNeil Consumer Healthcare Division of McNeil-PC, Inc. announced plans Thursday for new dosing instructions lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the U.S. from eight pills per day (4,000 mg) to six pills per day (3,000 mg).

The change is designed to help encourage safer acetaminophen use with the intention of reducing risk of accidental overdose.

Acetaminophen is the active ingredient in Tylenol and can be found in more than 600 over-the-counter and prescription medications, such as Sudafed Triple Action, NyQuil, Percocet and Vicodin. It is used by more than 50 million Americans each week to treat conditions such as pain, fever, and cold and flu symptoms.

“Acetaminophen is safe when used as directed,” said Edwin Kuffner, M.D., vice president of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare. “But, when too much is taken, it can cause liver damage.  Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions.  McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.”

McNeil says the new dosing instructions will appear on Extra Strength Tylenol packages in the U.S. beginning in the fall of 2011. Additionally, McNeil will be lowering the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen-containing products.

Copyright 2011 ABC News Radio


FDA, DOJ Take Action Against Johnson & Johnson-McNeil

Cristina Arias/Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration and the Department of Justice announced Thursday afternoon that McNeil Consumer Healthcare (a unit of Johnson & Johnson) and two of its executives have been accused of violations of federal law for failing to comply with good manufacturing practices in connection with a series of product recalls and poor inspection reports at its manufacturing facilities.
Without admitting or denying the allegations, McNeil has entered into a consent decree with the government that places three of the company’s plants under supervision of the FDA. The decree also prevents them from reopening their Fort Washington, Pa. plant until it has been found by the FDA to be in compliance with the law.
McNeil can continue operating two of its other plants, one in Puerto Rico and the other in Lancaster, Pa., but the company must submit to independent inspections and adhere to a strict timetable to bring those facilities into compliance.

Copyright 2011 ABC News Radio 


McNeil Issues Voluntary Recall on Common Over-the-Counters

Photo Courtesy - Getty Images(FORT WASHINGTON, Pa.) -- McNeil Consumer Health Care initiated a voluntary recall on certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol upper respiratory products, Benadryl, Sudafed PE and Sinatab products distributed in the United States, the Caribbean and Brazil.  These particular lots were manufactured at the McNeil plant in Fort Washington, Pa. prior to April 2010 when the facility's activity was suspended.  

While McNeil says the quality of these products has not likely been compromised, the pharmaceutical company is taking this precautionary measure after discovering that many of the plant's equipment cleaning procedures were not up to adequate standards or were not properly documented.  The company highlighted in a statement that the recalls are not due to "adverse events."

McNeil is also recalling certain lots of Rolaids Multi-Symtom Berry Tablets distributed in the United States to bring the product's labeling up to regulation standards.

All recalls will happen at the wholesale level only.  McNeil says that "no action is required by consumers or healthcare providers.

Copyright 2011 ABC News Radio


13 Million Packages of Rolaids Recalled

Photo Courtesy -- McNeil Consumer Healthcare(FORT WASHINGTON, Penn.) -- Johnson & Johnson recalled over 13 million packages of Rolaids antacids Thursday after reports that metal and wood particles were found in the products.

The voluntary recall of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews follows "a small number of adverse reports associated with the product being recalled," according to information posted on the Rolaid's website.

Vomiting, gum and tooth injury, and abnormal taste were among the adverse reactions reported. J&J's McNeil Consumer Healthcare business, which sells the products, stated that "risk of serious adverse health consequences [in connection with the recalled products] is remote," but have nonetheless advised consumers to discontinue use at this time.

The company says the materials were potentially introduced into the products during the manufacturing process at an outside plant, but McNeil spokeswoman Bonnie Jacobs declined to provide ABC News with the identity of this third-party manufacturer.

While McNeil investigates the cause of the recall, the company has suspended production of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews and Rolaids Multi-Symptom plus Anti-Gas Softchews.

Copyright 2010 ABC News Radio

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