McNeil recalls children’s BENADRYL Allergy FASTMELT tablets

The recall initiative by McNeil

McNeil Consumer Health care, Division of McNeil –PPC, Inc., in consultation with the U.S Food and Drug Administration (FDA) has recalled certain products. This is a voluntary recall of the following products:

All product lots of Children's BENADRYL® Allergy FASTMELT® Tablets (in Cherry and Grape Flavors) distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas.

All product lots of Junior Strength MOTRIN® caplets , 24 count, distributed in the U.S

The recall was initiated at the wholesale and retail level. The company said no action was required on the part of consumers or health care providers.  Consumers could continue using the products. The recall was decided upon after a review under the company’s Comprehensive Action plan brought to light, inadequacies in the development of manufacturing process. There is no indication that the recalled products do not meet quality standards. The recall has not been triggered by adverse events.

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 tell 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 appear in 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 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.

Example

McNeil Consumer Healthcare recalled three TYLENOL® Cold Multi-Symptom liquid products from wholesalers and retailers in consultation with the FDA for updating the labels. It was not driven by adverse effects. No action was required on the part of consumers or health-care providers.  Consumers could continue using the product.