Many of America's best known consumer healthcare brands were caught up in a "voluntary" recall of contaminated products J&J announced late Friday January 15th.   The FDA issued a formal warning to J&J after an audit of its Puerto Rican plant.  While J&J failed to react and withheld information from FDA for well over a year millions of consumers were exposed to a little-known chemical contaminant.   Worse in a guarded, carefully worded press release Friday J&J chose not to identify the brand names affected either in the text or the title of its press release instead resorting to a lengthy separate pdf attachment.  That fourteen page attachment testifies to the extent and complexity of the recall as does a new website dedicated to the recall.  In fact, consumers must work through the fine print to get the information they need.  As it turns out 53 million bottles of pills are being recalled across iconic brands such as Tylenol, Rolaids, Benedryl and Motrin, or one bottle for every five adult consumers in the U.S.  Over the last two years J&J, P&G and Chattem (Sanofi) have received warning letters concerning serious quality failures causing injury to consumers buying OTC branded products.  If iconic brand names no longer provide an assurance of safety why take a chance with Tylenol, or any OTC brand, with cheaper store brands widely available?

 

It used to be that buying a branded product implied an assurance of safety while store brands were suspect.  Now the reserve seems true.  Store brands have had few if any formal FDA actions against their products while companies such as J&J, P&G and Chattem (Sanofi) have had serious safety incidents resulting in warning letters, side effects and personal injury.  These incidents seem driven by failures in the attention given to quality assurance, to product designs that ignore consumer safety, and to efforts to "contain" self-inflicted behaviors or cost.

First the facts... the brands affected include Tylenol Children's, Extra Strength, Regular, 8hr, Arthritis, and PM; Motrin Children's and IB; Rolaids; Benedryl; Simply Sleep; and St Joseph's Asprin.  Although the final distribution points of these contaminated lots is unknown to us this must be considered nationwide and transnational in scope.

In December 2009 J&J initiated a single product recall of certain lots of Tylenol Arthritis EZ Cap manufactured at this plant.  At the time OTC Product News had suggested this recall resulted from a plant-wide, not simply a single product, contamination.  Apparently we were correct as it now appears that all products made in this plant have been recalled after the  FDA conducted an audit of the plant. The working assumption by FDA is that a fungicide on shipping pallets is responsible.  We contend that two factors might have contributed to this incident:  1) wooden pallets were favored compared to the cost plastic pallets; and 2) sanitation and cleaning procedures with bleach further degraded the fungicide to produce the contaminant.

Exacerbating these failures in the quality and manufacturing systems at the plant is management's failure to react to the situation in an proactive and responsible manner according to FDA.  The original observations of the contamination date back to early 2008.  Their behavior in managing the initial incident and its repeated failure to react to consumer complaints of injury is at best irresponsible.  Deborah Autor at FDA is quoted to have said:  "When something smells bad, literally and figuratively, companies must aggressively investigate".

Unlike their famed handling of the 1982 Tylenol tampering incident, recently in the news again, J&J has moved surreptitiously to report and resolve the initial contamination. The formal FDA warning letter cited J&J for failures in its handling and follow up of this contamination which began as early as the spring of 2008.  In addition to the likely contents of the 483 report of specific violations in the plant the FDA's warning letter of 15 January cited them for:  1) failure to investigate the root cause; 2) failure in the quality control system; 3) repeated failure to notify FDA.  In addition FDA cited senior management as responsible for these failures and that the investigation is far from closed.  In contrast to the insouciant attitude of branded manufacturers the track record for store brands, such as Perrigo's Equate (Walmart) has been relatively free of product failures.  The price/value proposition of store brands in a recessionary economy offers an attractive entry point for consumers who seek safe and effective products.

 

Exerpts from related stories:

Our Top Five Insights Of 2009

1/1/10:   #4 -  Up until recently J&J's Tylenol was the Tiger Woods of analgesics - squeeky clean and brilliantly effective.  In 2009 the hidden vulnerabilities of the brand, that were always known to insiders, began to expose themselves.  Tylenol suffered a series of bad press moments including a sweeping FDA mandate to reduce the drug's dose exposure across the board.  We saw this coming, but not the later plant contamination, nor the reports of unexpected effects on the immune system and asthma.

The Five Brands That Made News in 2009

12/31/09:   #1 -  Tylenol suffered a series of missteps, bad press and problems over 2009 that challenged the brand's long standing equity of safe use.  These included:  1) an FDA study group confirming the liver toxicity of acetaminophen as a concern; 2) the FDA acting to downsize the dosing instructions for acetaminophen including some combination products to avoid overdose;  3) bacterial contamination of a Tylenol product indicated for children; 4) chemical contamination of a Tylenol product indicated for the elderly; 5) a clinical trial demonstrating that acetaminophen dosing prior to vaccination of infants interferes with their immune response; and, 6)  a clinical review claiming that acetaminophen increases asthma risk by 1.6 times.  Much of this erosion can be attributed to a growing awareness of the drug's vulnerabilities versus its real world use, brand positioning and safety halo.

Tylenol's Safety Halo Tarnished By Plant Cont...

12/28/09:  J&J expanded its nation-wide recall of Tylenol Arthritis Pain (100ct bottle with EZ-Open Cap) today from 5 lots to 54 lots.  It appears consumers noticed a musty off-odor and some became ill with gastrointestinal distress.  This product is contaminated with 2,4,6-tribromoanisole, a degradant of a phenolic chemical used as either a fungicide in the preservation of wood, or as a fire retardant in plastics.  This caps a year of unrelated incidents each challenging Tylenol's heritage of safety.

[Dr. Riker is a former Associate Director, Personal Healthcare at Procter & Gamble, and the last Vice President of R&D & Chief Scientific Officer at Chattem]