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Wednesday, March 30, 2011

J&J Recall Watch: More Musty-smelling Tylenol Caplets

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That moldy odor has stricken more popular Johnson & Johnson medicines, prompting another recall of Tylenol. It was one of two new recalls J&J announced today. (Here’s the Dow Jones Newswires story.)

Due to complaints about the smell, Johnson & Johnson’s McNeil Consumer Healthcare unit said it’s pulling 34,056 bottles of Tylenol 8-Hour caplets. (Here’s the news release.)

The 150-count bottles were made at the company’s Fort Washington, Pa., plant, shut down since last April and now undergoing a re-fitting. J&J wouldn’t specify when the caplets were made, saying only that it was before the plant was shut down.

The odor problem prompted J&J to pull other medicines previously, most recently last October when more than 127,000 Tylenol 8-Hour caplet bottles were recalled.

In addition to recalling more the caplets, J&J also added 717,696 bottles or packages of Tylenol Arthritis Gel-Tabs, Tylenol Sinus, Tylenol 8-Hour, Benadryl Allergy Sinus Headache and Sudafed PE Cold/Cough Multisymptom to the list of medicines recalled from wholesalers on Jan. 14.

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

* J&J’s Animas unit recalled earlier this month 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.
* As Dow Jones Newswires reported recently, 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. Customers don’t need to return the products, which have the correct wording on the blister packs that hold the tablets. No adverse events have been reported as a result of the typo, J&J says.
* 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, Dow Jones Newswires 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 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 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 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. Contacts made in the U.S. aren’t affected.
* In November 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, 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 OTC 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.
* In June, 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.
* 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.
* J&J’s Ethicon unit withdrew 360,000 Blake Silicone Drains, J-VAC reservoirs and other products sold in the U.S. for draining surgical wounds.

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