ROLAIDS® Extra Strength Softchews being Recalled

McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc., has initiated, in consultation with the FDA, a recall of one product lot of ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package, distributed in the United States.  

A third party manufactured the product and the LOT number is 0053AG2, which is furnished on the back of the package. The recall is at the wholesale and retail levels. The recall was initiated after complaints were filed by consumers. The complaints concerned the product’s uncharacteristic consistency or texture, attributable to the presence of crystallized sugar in it. The recall was not initiated by adverse effects. Hence no action was required on the part of healthcare consumers or providers. Customers can continue to use the product.

Regulations

Manufacturers or distributors of a product voluntarily carry out most recalls of products regulated by FDA. A manufacturer / distributor may come to know that one of its products is defective and recall it spontaneously. Alternatively, the FDA may infer that the product is defective and call upon the manufacturer / distributor concerned to recall the product. Usually, the company will comply. If it does not, the FDA can seek legal action under the FD&C. Seizure of the stocked product, and/or injunction of the firm, including a court request for recall of the product are amongst the possible FDA actions. The joint effort of FDA and its regulated industries has proved successful over the years because neither of the two wants the consumers to suffer for a mistake they have not made.

FDA guidelines the companies should comply with while recalling defective products are furnished un-der Title 21 of the Code of Federal Regulations, Part 7. Accordingly, the FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Companies should notify FDA when they initiate recalls and periodically report the progress made on recalls to FDA. The guidelines categorize all recalls into Class I or Class II or Class III depending on the level of hazard involved. Class III recalls concern products that are unlikely to cause any adverse health reaction, but violate FDA labeling or manufacturing regulations. Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food. The instant case involving McNeil Consumer Healthcare qualifies as a Class III recall and the violation concerns manufacturing regulations.

Example

In Nov 2010, McNeil Consumer Health care, a division of McNeil –PPC, Inc., recalled certain products in consultation with the FDA. This was a voluntary recall of the following products: