Johnson & Johnson (J & J) enjoyed a halo effect for many decades after their iconic precautionary recall of Tylenol capsules in 1982, which was greatly facilitated by the famous Johnson & Johnson Credo1 that stipulated patient well-being to be paramount in importance. But that halo has now been lost due to the events that led to the company’s recall of children’s Tylenol and other children’s medicines in 2009 and 2010.

On April 30, 2010, J & J’s McNeil Consumer Healthcare, LLC (McNeil Division),

“recalled some 50 children’s versions of non-prescription drugs, including Tylenol, Motrin and Benadryl.”2 In total, 136 million bottles of liquid were involved.3 This was the fourth recall in seven months. Earlier recalls included the following:

• November 2009—five lots of Tylenol Arthritis Pain 100 count with the EZopen cap due to reports of an unusual moldy, musty, or mildew-like odor that led to some cases of nausea, stomach pain, vomiting, and diarrhea.

• December 2009—November recall expanded to all lots of the product.

• January 2010—an undisclosed number of containers of Tylenol, Motrin, and over-the-counter drugs after consumers complained of feeling sick from an unusual odor.4 The McNeil Division had four plants including those at Fort Washington, Pennsylvania

(operated as a joint venture with Merck & Co.), and Las Piedras, Puerto Rico. J & J shut down the Fort Washington plant in April 2010 just before an unannounced inspection from the U.S. Food and Drug Administration (FDA). But according to the FDA Statement to the Committee of Oversight and Government Reform of the U.S. House of Representatives on May 21, 2010,5 FDA concerns over the company’s manufacturing processes began several years earlier.

The FDA is responsible for ensuring that companies manufacture and distribute drugs that are safe for consumers in accordance with current Good Manufacturing Processes (cGMP) that cover minimum requirements for methods, facilities, and controls used in the manufacturing and packaging of the products. According to the FDA Report, Under the cGMP regulations, each manufacturer sets specifications for its own products for such factors as potency, stability and purity, and puts in place a quality system that ensures those specifications are met.

Critical to the cGMP process is that a company must meet its own standards.

A violation of cGMP does not necessarily mean that a product is hazardous to the public. It does indicate, however, a breakdown in a manufacturer’s quality system and is an indication that a company needs to take effective steps to fix the problem promptly.

FDA inspects facilities to ensure compliance with cGMP standards.

These inspections occur on average for domestic facilities every two to three years. We increase the frequency of inspections for facilities when warranted by past problems or by products that are difficult to manufacture or are especially high risk........

Questions:-

1. Who was really to blame for the lax procedures found?
2. How should this situation be remedied?
3. How could the job done by the FDA be improved?
4. J & J had lived under a positive halo due to their earlier recall of tainted capsules of Tylenol. Why did J & J people behave differently almost thirty years later?
5. How would the total cost of this debacle be estimated?