Tylenol 8 Hour Caplets Recalled

On October 18, 2010, McNeil Consumer Healthcare/Johnson & Johnson initiated their sixth recall of 2010, recalling one lot of Tylenol 8 Hour caplets, due to numerous complaints of a musty or moldy odor, which is causing consumers to suffer from cases of nausea, vomiting, and diarrhea.

According to the FDA, consumers who have purchased Tylenol 8 Hour Caplets from lot # BCM155 should stop using the product immediately.

The musty or moldy odor emitting from the Tylenol 8 Hour tablets stems from 2,4,6-tribromoanisole, which is a chemical contaminant that seeped into the empty Tylenol 8 Hour medicine bottles. According to the Journal of Agriculture and Food Chemistry, 2,4,6-tribromoanisole is an environmental contaminant that was most likely produced from 2,4,6-tribromophenol (TBP) by microbial activity. TBP is used as a fungicide and a wood preservative which is used in wooden pallets involved in the storage and transportation of the product at McNeil’s Las Piedras facility in Puerto Rico.

Additional Tylenol Recall

On July 8, 2010 McNeil Consumer HealthCare, a unit of Johnson and Johnson, announced another recall of Tylenol and other well known products.  This is the third recall of  Tylenol products in less than a year. In January 2010 a recall was initiated because of customer complaints of a musty odor. The odor has been linked to the presence of trace amounts of 2,4,6 tribromoanisol (TBA) which could cause illness in children. The recall was expanded again in April 2010 when the company recalled its children and infant liquid products following reports of failure to meet quality control guidelines.

The latest recall affects an additional 21 lots over-the-counter medications including Tylenol, Benadryl and Motrin, and brings the total number of recalled products to over 3 million.

Some critics argue that McNeil is not being cooperative regarding the number of bottles recalled, and is apparently trying to downplay the possible dangers and seriousness of their product with this latest recall. McNeil has publically stated that the recalls are a  “precautionary measure” and that "the risk of serious adverse medical events is remote.”

Johnson & Johnson, once a very respected company, is now under great congressional investigation and scrutiny from the U.S. Food and Drug Administration. Furthermore, consumers are worried that the medications they have trusted for years are no longer safe for their children. Due to the lack of cooperation regarding releasing the number of lots recalled and other concerns, a Congressional investigation of Johnson and Johnson is underway. Dr. Joshua Sharfstein, The Food and Drug Administration's principal deputy commissioner, cited "significant violations" of manufacturing regulations by McNeil Consumer Healthcare”.  The FDA is looking into a pattern of quality control procedures and violations in manufacturing. Chairman Towns and Ranking Member Issa of The Committee on Oversight and Government Reform, “want to bring attention to the recall particularly due to the fact that children could be adversely impacted if they were to take any of the medicine that was covered by the recall”.

Update: 6/2/2010: Additional Over-The-Counter Children's Medicines Recalled

On April 30, 2010, McNeil Consumer Healthcare recalled over 40 forms of Tylenol Infant Drops, Children's Tylenol Suspensions, Children's Tylenol Plus Suspensions, Motrin Infant Drops, Children's Motrin Suspensions, Children's Zyrtec Liquid in Bottles, and Children's Benadryl Allergy Liquid after the medications were found to be contaminated during the manufacturing process at their Fort Washington, Pennsylvania plant. McNeil said that some of the drugs may contain a higher concentration of active ingredient than is specified, while others may contain inactive ingredients that may not meet internal testing requirements.

In addition to these recalled products, more children's products were recalled on May 28, 2010. Blacksmith Brands, Inc. and the FDA issued a recall of four types of PediaCare over-the-counter children's medicines because they were produced at the same McNeil Consumer Healthcare plant where the contaminated Tylenol products were manufactured. The recalled PediaCare products include PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9, PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7, PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8, and PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4.

The Fort Washington plant has been temporarily shut down, pending further investigation. A recent inspection at the facility found contamination issues and the FDA's current good manufacturing practices were not met. According to Blacksmith Brands, Inc., "although the recall was not initiated as a result of adverse events or complaints with respect to the PediaCare products, tiny particles have been found in other non-PediaCare products which were manufactured at the McNeil plant." The company is advising parents to discontinue PediaCare use immediately.

According to a Reuters report, "the recall was the largest involving children's medicines in the history of the FDA, and involved 70 percent of the market for over-the-counter pediatric liquid medicines." A Congressional memo stated that between January 2008 and April 2010, the FDA received 775 reports of adverse events, including 30 deaths involving the recalled Tylenol, Benadryl, and Zyrtec products. The memo also said that after the widely publicized recall, the agency received over two hundred additional complaints, including seven deaths. The FDA is still investigating these reports to determine if the events were related to a child taking one of the possibly contaminated medications. In light of the contamination at the Fort Washington plant, the FDA had decided to widen its investigation of McNeil's manufacturing practices, and it is now inspecting the company's other facilities in Puerto Rico and Lancaster, PA.

McNeil Consumer Healthcare Announces Recall of Over-theCounter Children's Liquid Medicines, including Tylenol, Motrin, Benadrylm and Zyrtec

On April 30, 2010, McNeil Consumer Healthcare, working with the Food and Drug Administration (FDA) announced the recall of infant and children's liquid products after the FDA discovered that liquid children's Tylenol, Motrin, Benadryl, and Zyrtec were contaminated as the result of the manufacturing plant not following the correct procedures. This contamination can potentially affect the potency, quality, and safety of the drugs. The products include infant and children's Tylenol, Motrin, Benadryl, and Zyrtec 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.

This is the fourth recall conducted by McNeil in the past seven months. According to CNN, in November 2009, "five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for emitting an unusual odor which lead to nausea, stomach pain, vomiting and diarrhea. In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap. In January 2010, the recall was further extended to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor." After months of speculation, the issue was linked to chemically treated wooden pallets being used in the manufacturing plant.

According to the FDA, manufacturing deficiencies warrant this recall on children's and infant's drugs made by McNeil Consumer Healthcare. 40 types of liquid formulations are on the recall list due to a bacterial contamination found in one of the raw ingredients used to make Tylenol. According to the FDA, there is no evidence that the contamination is found in any finished products, thus far. The recalled products include all Tylenol Infant Drops, Children's Tylenol Suspension, Children's Tylenol Plus Suspension (regular and dye-free), Concentrated Motrin Infant Drops (regular and dye-free), Children's Motrin Suspension, Children's Motrin Cold Suspension, Children's Zyrtec (sugar-free and dye-free), and Children's Benadryl Allergy Sugar-free. The FDA is currently investigating complications associated with the above-mentioned drugs. According to a U.S. Congressional report, the FDA is also investigating 775 serious side-effects, including 30 deaths related to the complications, but no direct link has been found as of yet. Following the recall, several hundred more cases of complications, including seven deaths, have been reported to the FDA.

Following this recall, all production at the Fort Washington plant has been suspended, pending further investigation. In the FDA's report of the plant, there were 20 violations. An alarming violation claims that the plant did not "maintain adequate laboratory facilities for the testing and approval (or rejection) of components of drug products." Between June 2009 and April 2010, McNeil Pharmaceuticals failed to address 46 complaints they received from consumers, the FDA claims. Conditions were also stated to be "dusty and filthy." According to McNeil, "comprehensive quality assessment is being conducted across its manufacturing operations and corrective actions will be implemented before new manufacturing is initiated at the plant."