(Editor's Note: Sanofi announced on Jan. 7, 2013, that its U.S. consumer health care division, Chattem Inc.,has acquired the worldwide rights to the Rolaids brand from McNeil Consumer Healthcare. Therefore, information that originally appeared on McNeil's Rolaids website is no longer available.)
McNeil Consumer Healthcare is voluntarily recalling 130 lots of Rolaids because of consumer reports of foreign materials in the products, including metal and wood particles, the company said in a Dec. 9 news release(www.fda.gov) posted on the FDA website.
The recall affects all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength Plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews. McNeil said it has suspended production of all three products and will not resume production until corrective actions have been implemented.
According to the company's news release, the potential for serious adverse health consequences is remote, but the company advised consumers to discontinue use of the recalled products. Consumers seeking a refund may contact McNeil online or by calling (888) 222-6036.
Adverse reactions may be reported to the FDA's MedWatch program(www.fda.gov).
McNeil initially recalled one lot of Rolaids Extra Strength Softchews in mid-November after the company received consumer complaints of "an uncharacteristic consistency or texture, traced to crystallized sugar in the product."
Rolaids was one of four McNeil product lines subject to November recalls. The company's other recent recalls involved the following products:
- Three Tylenol Cold Multi-Symptom products were recalled Nov. 24 because the front labels of the 8-ounce bottles failed to mention that the products contain alcohol. The affected products are Tylenol Cold Multi-Symptom Severe Cool Burst, Tylenol Cold Multi-Symptom Nighttime Cool Burst and Tylenol Cold Multi-Symptom Daytime Citrus Burst.
- All product lots of Children's Benadryl Allergy Fastmelt Tablets in cherry and grape flavors and all product lots of 24-count Junior Strength Motrin Caplets were recalled after a review revealed "insufficiencies in the development of the manufacturing process." McNeil said in a Nov. 15 news release that the recalls were not being undertaken on the basis of adverse events.
McNeil has had numerous recalls this year, leading to a company-wide investigation by the FDA, as well as hearings by the U.S. House Committee on Oversight and Government Reform in May and September. Officials from McNeil's parent company, Johnson & Johnson, testified at those hearings.
In January, the company recalled more than 500 lots of its OTC products -- including Benadryl, Rolaids, multiple formulations of both Motrin and Children's Motrin, and numerous formulations of Tylenol and Children's Tylenol -- in the wake of consumer complaints of moldy, musty or mildew-like odors.
The smell was linked to trace amounts of 2,4,6-tribromoanisole, a degradant of 2,4,6-tribromophenol, which is a fungicide, wood preservative and flame retardant used to treat wooden pallets.
That recall was expanded multiple times, most recently in July.
In addition, McNeil recalled all lots of more than 40 formulations of its children's and infants' allergy and pain relief products on April 30 because of manufacturing deficiencies that could affect the products' quality, purity or potency. The company announced June 24 that those products would not return to the market(www.jnj.com) before the end of the year.