McNeil recalls Rolaids on particle contamination
pharmafile | December 14, 2010 | News story | Manufacturing and Production | J&J, JJ, McNeil, Rolaids, particulate contamination, pharmaceutical manufacturing, product recalls
Recalls at Johnson & Johnson are coming thick and fast at the moment. In the latest incident the firm’s troubled McNeil Consumer Health unit is calling back around 13 million packs in its Rolaids antacid range because of particulate contamination.
The latest recall – thought to be the fifteenth of the year for J&J – came on the back of consumer complaints of wood and metal particles in the Rolaids products which, it appears, were made not by McNeil but by a contract manufacturer.
The recall affects Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews distributed in the US, and Rolaids Ultra Strength Softchews and Rolaids Ultra Strength Softchews plus Gas Relief distributed in Canada.
J&J said in a statement it had initiated an investigation into the incident.
“While our investigation is ongoing we have suspended production of [the products] and will not restart production until corrective actions have been implemented,” it added.
McNeil also recalled one lot of Rolaids Extra Strength Softchews in November following consumer complaints of an uncharacteristic consistency or texture, traced to crystallised sugar in the product. In that instance too the product was made by a contract manufacturer.
“While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use,” the company said.
The recall brings the tally of J&J brands subject to recall to more than 40 since the start of the year, and the company has shuttered one manufacturing facility in Pennsylvania while another in Puerto Rico is under scrutiny by the FDA.
J&J has already been called in front of the US Congress twice to explain its manufacturing problems and the latest recall will only serve to heighten concerns about the company’s quality control procedures.
Phil Taylor
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