Years ago, I used to teach public relations courses called Reputation Management to corporate suits.  When I singled out companies that had somehow managed to weather bad press to emerge with reputations well intact, there was one at the top.

That company poster child was, hands down, Johnson & Johnson.

In fact, for many years the Forbes list of 100 Most Admired Companies featured J&J as their perennial list-topper. And the exemplary way the company had swiftly stick-handled its catastrophic Tylenol murders scandal in 1982 continues to be taught in PR, journalism and crisis communications classes.

But those heady days must seem far, far away now, with increasing reports of tainted J&J drug recalls. As Consumer Reports Health describes it, a nauseatingly bad smell to its products has been blamed for stinking up several different types of Tylenol, the antipsychotic drug Risperdal, HIV/AIDS drug Prezista, and two lots of the anti-epilepsy drug Topamax among many others. In fact, the agency reports that recalls like these have cost J&J almost $900 million in sales last year alone.  

The latest recalled culprits were the company’s Extra-Strength Tylenol caplets. J&J’s McNeil Consumer Healthcare division recently pulled over 60,000 boxes of the painkiller in the U.S. following reports of a noxious smell in the products.

One wonders if this rash of recalled drugs might just have something to do with the fact that an estimated 40% of the active ingredients for North American drugs now comes from India and China. As the Washington Post reports:

“Our analysts estimate that as much as 20% of finished generic and over-the-counter drugs and more than 40% of the active ingredients for pills made here come from overseas sources. Within 15 years, as much as 80% of the key ingredients will be imported.”

William Hubbard, a former FDA associate commissioner, described this outsourcing as “dire and deteriorating”.

“In 1999, India did not appear on an FDA chart of master files. By 2004, almost half of the reviewed files for drug ingredients destined for U.S.  patients came from Indian companies.

“More recently, Indian companies have moved more aggressively into making finished drugs, and Chinese companies have expanded their share of the market in active ingredients.“

According to Roger Bate of the American Enterprise Institute in his Manufacturing News report last May:

“The increasing reliance on active pharmaceutical ingredients made in unreliable plants, particularly in China, is part of the problem. In 2002, the U.S. imported $331 million in drug products from China – by 2010, it was $1.74 billion.

“There are good reasons for sourcing chemicals from China, since it produces them more cheaply than anywhere else on the planet. We would pay a lot more for drugs if companies didn’t buy ingredients from China, which is why, with constant pressure to lower drug prices, pharmaceutical manufacturers flock to China.

“But some western companies have behaved naïvely, implicitly assuming that cost savings are made through lower labor costs and large economies of scale, not through systemic corner cutting.”

Cynthia Reilly, a director of the American Society of Health-System Pharmacists, suggests that we are already at greater risk every day because of these drug chemicals coming from China, explaining:

“It’s not through lethal products, but because quality is lower, causing far more product recalls, and hence drug stockouts.”

Meanwhile, without casting blame on imported drugs or indeed any one single  factor, Consumer Reports Health has been keeping tabs on J&J’s growing string of recalls. Here’s their running list so far:

• In mid-June, J&J pulled 16,000 bottles of Risperdal due to odor issues.
• J&J said in May it would pull an estimated 2,000 bottles of Prezista in four European countries due to odor issues.
• In April, J&J recalled about 57,000 bottles of Topamax because of the bad smell.
• In late March, J&J’s McNeil Consumer Healthcare pulled about 34,000 bottles of Tylenol 8-Hour Extended Release caplets because of a musty odor. Separately, it widened a wholesale-level recall of Tylenol, Benadryl and Sudafed products.
• Also in March, J&J’s Ethicon unit recalled about 360,000 units of surgical-wound draining products on concerns that the package’s sterility could be compromised.
• Earlier that month, J&J’s Animas unit recalled more than 384,000 insulin-pump cartridges in the U.S. and France, saying they have the potential to leak and give a too-low dose, as Dow Jones Newswires reported.
• Dow Jones Newswires also reported recently that J&J’s Ethicon unit issued a late-December alert in the U.K. that it was recalling about 585,000 surgical sutures. The sutures were mostly sold in Europe.
• In late February, J&J recalled more than 667,000 Sudafed packages at the wholesale level after a typo on the packaging (“do not not divide, crush, chew, or dissolve the tablet”) was discovered.
• Earlier in February, J&J said it was pulling at least 395 injection pens preloaded with rheumatoid-arthritis drug Simponi because they may not deliver a full dose of the drug.
• Just days before that announcement, Dow Jones Newswires reported that the company’s Ethicon unit had recently recalled 700,000 vials of a liquid wound sealant and also a hernia-treatment product.
• Earlier that same week, J&J said it was recalling 70,000 syringes preloaded with its Invega injectable anti-psychotic drug because cracks have been found in the syringes that could lead to infections or under-dosing in users.
• In January, J&J said it would pull 43 million bottles of certain Tylenol, Benadryl, Sinutab and Sudafed products because they were made at the company’s Ft. Washington, Pennsylvania plant at a time when equipment may not have been properly cleaned. J&J also said it would pull almost 4 million units of Rolaids due to a labeling problem.
• In December, the company said it was recalling all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength Plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews following consumer reports of foreign-particle contamination.
• A few weeks earlier, J&J recalled a dozen different Mylanta liquid products and one AlternaGEL product because they were mislabeled to omit the presence of alcohol. And it separately widened a recall of daily-use contact lenses in Japan and elsewhere due to traces of an acid that can cause stinging.
• In November, the company recalled three Tylenol Cold Multi-Symptom products, also pulled from retailers and wholesalers due to an alcohol labeling issue.
• Also in November, the company recalled children’s Benadryl and Motrin products.
• In October, there was a recall of 127,000 bottles of Tylenol 8-Hour caplets due to a musty odor.
• In August, J&J’s DePuy Orthopedics unit pulled two hip implants off the market because of an unusually high rate of replacement surgeries.
• Also in August, there was a recall — the one that was recently widened — of about 100,000 boxes of 1-Day Acuvue TruEye contact lenses.
• Some over-the-counter medicines were pulled in July, including varieties of Benadryl, Tylenol and Motrin. This was a follow-up to a recall of musty-smelling products made at a plant in Puerto Rico.
• The company then widened the recall of drugs made at the Puerto Rican plant by five lots.
• The largest batch of J&J’s children’s medicines were pulled in the spring.
• In late 2009, there were recalls of Tylenol Arthritis Pain Caplets due to that musty odor issue.
• J&J officially recalled batches of Motrin in July 2009, but has come under fire for an earlier so-called “phantom recall” of the product.

By the way, Consumer Reports Health has this advice today if you’re a regular Extra-Stinky Tylenol user:

“Look for store-brand or generic versions of acetaminophen instead. Generic acetaminophen typically costs much less than brand-name Tylenol versions, is just as safe and effective, and has not been implicated in these recalls.”

See also:

• Do You Want To Take Medications Made in China?
• Why Big Pharma Now Outsources Its Clinical Trials Overseas