The Recalls Keep Piling Up for J&J

McNEIL CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF ALL LOTS OF ROLAIDS® EXTRA STRENGTH SOFTCHEWS, ROLAIDS® EXTRA STRENGTH PLUS GAS SOFTCHEWS, AND ROLAIDS® MULTI-SYMPTOM PLUS ANTI-GAS SOFTCHEWS SOLD IN THE UNITED STATES

No sooner had Secure Pharma Chain posted it blog from Pharmalot but comes more bad news from the pharmaceutical industry giant.

In a seemingly never-ending story, Johnson & Johnson’s embattled McNeil Consumer Healthcare unit has issued yet another recall, this time for its ubiquitous Rolaids brand.

It remains to be seen how many hits to its venerable brands can the industry giant take and retain its trust regarding the safety and efficacy of its respected and ever-present products with consumers.

J&J explains the recall in its press release with the following:

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

J&J is feeling the immediate financial impact of the loss of sales, expense of recalls and operational expenses. The long term impact in liabilities, brand erosion and loss of consumer confidence will continue to accrue for many years to come.

Members of the pharmaceutical supply chain (manufacturers, distributors and dispensers) should take heed from the woes of J&J. Testing and protection of the brand and inventories from poor quality, fraud, adulteration and counterfeiting does not stop at any one point of the supply chain process. Measures must be deployed at all stops of the supply chain to test the quality and authenticate that the product being consumed is safe and efficacious.

To read the entire official J&J Press Release regarding the recall and its details, visit: http://www.rolaids.com/page.jhtml?id=rolaids/include/recall_dec.inc

To learn about supply chain authentication technologies, visit: http://www.xstreamsystems.net/

Pharmalot: Another Day, Another Johnson & Johnson Recall

Ed Silverman continues his insightful and humorous blogging on yet another recall from J&J’s McNeil Consumer Health unit:

Highlighted in Mr. Silverman's blog:

• Once again, Johnson & Johnson has yanked a huge amount of over-the-counter medicines. This time, the recall involved about 4 million packages of children’s Benadryl allergy tablets and about 800,000 bottles of children’s Motrin caplets from pharmacies and distributors due to “inefficiencies” in manufacturing.

• Specifically, all product lots of Children’s Benadryl Allergy Fastmelt Tablets in cherry and grape flavors distributed in the US, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength Motrin Caplets distributed in the US. However, there was no indication of any adverse event reports or that the products “do not meet quality standards,” she wrote. Consequently, consumers can continue to use the products.

• Unlike the series of previous recalls, the health care giant did not issue a press release to announce these moves. When asked to explain the difference in procedure, the spokeswoman wrote this is considered a distributor recall, but that the info was posted on the individual product web sites on Nov. 15.

• Tens of millions of bottles have since been recalled; a plant in Fort Washington, Pa., has been shuttered and may be retrofitted; some 300 plant workers lost their jobs; Congressional hearings have been held; federal and state investigations are under way; consumer confidence in the company is falling; a quality control guru was appointed at the corporate level and at least $600 million in sales will be lost this year.

Since the posting of the Pharmalot blog, J&J has added another recall, this time of nearly 9 million bottles of Tylenol.

At some point, it seems logical that J&J would aggressively be doing everything in its power to alleviate these quality control issues.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/11/another-day-another-johnson-johnson-recall/

Johnson & Johnson, The Recalls Continue

J&J recalls more Tylenol, over-the-counter drugs, recalled lots linked to odors.

Johnson & Johnson recalled more Tylenol and other over-the-counter drugs on July 8th after the 21 lots of Tylenol, Benadryl and Motrin were linked to a musty or moldy odor. This action continues to expand a recall the company’s McNeil Consumer Healthcare unit started in January.

Johnson & Johnson’s McNeil Consumer Healthcare unit said the latest recall involved 21 lots of medications, including Tylenol for children and adults, several forms of Benadryl allergy tablets and Motrin painkiller. However J&J spokesperson Bonnie Jacobs was unable to disclose how many pieces were in each lot or give a total number of items involved.

Thursday's recall, like the one in June, was related to J&J's January recall of 53 million bottles of widely used products, which were also linked to odors.

On June 15, J&J recalled four lots of Benadryl and one lot of Extra Strength Tylenol gels.

"These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots," Johnson & Johnson said in a press statement.

As with the previous recalls, Johnson & Johnson are encouraging consumers who have purchased the products included in the recall should stop taking them and contact the company about a refund or replacement

Not counting the subsequent follow up recalls to the January 15th recall, McNeil has issued four product recalls in the past year due to quality control problems at its plants, sparking a congressional investigation and scrutiny from the U.S. Food and Drug Administration.

Secure Pharma Chain Blog encourages all within the pharmaceutical supply chain to authenticate and verify the quality of their inventories while protecting consumers from fraud, adulteration and counterfeit product.

To learn more about pharmaceutical supply chain solutions to quality control and product authentication, visit: http://www.xstreamsystems.net/.

McNeil Announces Sweeping Recall of Infants’ and Children's OTC Products

In an April 30th announcement, McNeil Consumer Healthcare in consultation with the U.S. Food and Drug Administration (FDA), stated that they are voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products 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.

McNeil Consumer Healthcare stated that they were initiating this voluntary recall because some of these products may not meet required quality standards.

According to McNeil the recall is not being undertaken on the basis of adverse medical events but as a precautionary measure and advises parents and caregivers should not administer these products to their children.

Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.

While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

For a complete list of the products, visit: http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.