J&J Recall Watch: McNeil Pulls Liquid Infant Tylenol on Dosing System Concerns

By Katherine Hobson

Johnson & Johnson’s McNeil Consumer Healthcare division is recalling about 574,000 one-ounce bottles of grape-flavored liquid infant Tylenol after receiving a small number of complaints that the dosing system was difficult to use.

Some consumers reported that one part of the dosing system, the flow restrictor, was pushed into the bottle. If that hasn’t happened, consumers can keep using the product, Dow Jones Newswires reports. No adverse events associated with the problem have been reported, the company says.

We’ve been keeping tabs on J&J’s string of recalls, which cost it about $900 million in sales in 2010, denting sales last year as well. Here’s a running list:

In December, J&J recalled about 12 million bottles of Motrin brand painkillers because some pills may not dissolve quickly, delaying pain relief. In September, J&J pulled about 200,000 syringes of its Eprex anemia drug at the wholesale and pharmacy level because some batches of the drug might not have been sufficiently potent. In August, J&J said it was recalling from wholesalers and stores almost 2.5 million packages of Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps due to higher-than-expected levels of a certain compound. In late June, McNeil Consumer Healthcare division said it was pulling one lot, or 60,912 bottles, of Extra-Strength Tylenol in the U.S. following “a small number of odor reports.” The smell has been linked to trace amounts of a chemical that’s a byproduct of a preservative sometimes applied to wooden pallets used in storage and transportation. It’s not toxic but can cause GI upset. In mid-June J&J pulled 16,000 bottles of Risperdal due to the same odor issues. J&J said in May it would pull an estimated 2,000 bottles of Prezista in four European countries due to odor. In April J&J recalled about 57,000 bottles of Topamax because of the smell. In late March, 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. 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. Days before, we reported that the company’s Ethicon unit 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 theoretically lead to infections or under-dosing in users. In January 2011, 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, Pa., 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 2010 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 small amount of alcohol. (Consumers don’t need to stop using the products or return them to stores.) 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 2010 the company recalled three Tylenol Cold Multi-Symptom products, also pulled from retailers and wholesalers due to an alcohol labeling issue. Consumers can keep taking the meds, J&J says. Also in November the company also recalled children’s Benadryl and Motrin products. Again, J&J said they weren’t dangerous and consumers didn’t have to stop taking them. In October 2010, there was a recall of 127,000 bottles of Tylenol 8-Hour caplets due to a musty odor. In August 2010, 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 — later widened — of about 100,000 boxes of 1-Day Acuvue TruEye contact lenses. Some OTC medicines were pulled in July 2010, 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. In June 2010, the company widened the recall of drugs made at the Puerto Rican plant by five lots. The largest batch of children’s medicines were pulled in the spring of 2010. 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.

Photo: Associated Press

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J&J Recall Watch: McNeil Pulls Liquid Infant Tylenol on Dosing System Concerns