Foreign materials found in Rolaids® Extra Strength Softchews, Roldaids® Extra Strength Plus Gas Soft-chews, and Roldaids® Multi-Symptom Plus Anti-Gas Softchews: McNeil recalls all Lots Voluntarily

• Date: December 28, 2010
• Source: Admin

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., has voluntarily recalled all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews distributed in the United States. The recall was issued after the presence of foreign materials in the product, including metal and wood particles, was reported. The company’s investigations have led it to conclude that the materials possibly found their way into the product during its manufacture at a third party facility. The FDA has since suspended production of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews even as its own investigations into the matter continue. Production will resume once corrective actions are implemented. This recall was conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Although the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare has advised consumers not to use the product by way of abundant caution. In particular, consumers who have medical concerns or questions should contact their healthcare provider.

Regulations

The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. The U.S. Food and Drug Administration (FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203). It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It is designed to discourage the sale of counterfeit, adulterated, misbranded, sub-potent, and expired prescription drugs. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded drugs from the market.

Source:  

http://www.fda.gov/Safety/Recalls/ucm236715.htm

http://en.wikipedia.org/wiki/Food_and_Drug_Administration