Pediatric medication recall: Generics, house brands fill void

September 15, 2010

Generic manufacturers and consumer budgets are the big winners in the ongoing voluntary recall of millions of packages of pediatric liquid medications manufactured by McNeil Consumer Healthcare.

Key Points

Generic manufacturers and consumer budgets are the big winners in the ongoing voluntary recall of millions of packages of pediatric liquid medications manufactured by McNeil Consumer Healthcare. Recalled products include children's Tylenol (acetaminophen), Motrin (ibuprofen), Zyrtec (cetirizine), and Benadryl (diphenhydramine) in drop, suspension, and liquid formulations.

"I tell patients to skip the brand and buy the generic or the house brand," said pharmacist Bob Brown, who works in several pharmacies near Cambria, Calif., midway between San Francisco and Los Angeles. "Even if you're just buying one package, you can save enough to buy a gallon of milk and still spend less than if you were buying the McNeil product."

Brown's advice to skip the branded version echoes that of FDA Commissioner Margaret Hamburg. Just days after the April 30 recall, she began urging consumers to use generics in place of the recalled medications. Johnson & Johnson, which owns McNeil, recalled the products because of contamination, excessive levels of active ingredient, and other manufacturing problems. This was Johnson & Johnson's sixth product recall since September 2009.

The question is whether consumers will go back to branded products once the recalled items return to the shelves.

"Independents are moving patients to house brands, and Walgreens is running full-page newspaper ads trumpeting their 25,000 pharmacists who are ready to help find alternatives, which means the house brand," said Frederick S. Mayer, RPh, MPH, president of Pharmacists Planning Services Inc. and a member of Drug Topics' editorial advisory board. "J&J has got to be wondering how it will ever recover market share after all these recalls."

Violations of good manufacturing practices

Johnson & Johnson and FDA reported contamination by potentially infectious bacteria as well as metallic particles and wood preservatives. An FDA inspection of McNeil's plant in Fort Washington, Penn., found multiple violations of good manufacturing practices. Johnson & Johnson closed the plant and has announced plans to revamp the facility before reopening it sometime in 2011.

Johnson & Johnson not only faces multiple lawsuits over the contaminated products; during a telephone conference with financial analysts, a company representative disclosed the fact that the company also faces a federal grand jury investigation. FDA reported in May that it had turned the matter over to its criminal investigative unit. FDA inspections also have uncovered manufacturing deficiencies at McNeil plants in Lancaster, Penn., and Las Piedras, Puerto Rico. FDA reported that approximately 4 dozen consumers have complained of foreign particles or bad smells coming from McNeil products.

Public response is muted

Pharmacists say the recall has gone largely unnoticed outside the profession.

"We get occasional calls whenever the media runs a new story," Matt Mallinson, RPh, owner of Matt's Medicine Store in Independence, Mo., told Drug Topics. "But almost everybody uses my house brands anyway. Most people don't even know about the recall unless they see an empty spot on the shelf."

Pharmacy organizations report similar attitudes across the country.

"There doesn't seem to be a lot of concern on the part of parents," said Lisa Fowler, PharmD, director of management and professional affairs, National Community Pharmacists Association. "For the pharmacist, the recall is a real opportunity to open the conversation about house brands and generics."

That wasn't always the case. In the weeks immediately following the recall, many wholesalers limited purchases of generics because of supply shortages, said Benson Toy, PharmD, CCN, owner of Marin Medical Pharmacy in San Rafael, Calif. Shortages disappeared by midsummer, he added.

"With three pediatricians in the building, we get a lot of requests for drops and suspensions," Toy said. "The doctors all have preprinted Tylenol pads where they just check boxes for body weight and formulation. That has always been an opportunity for education and product recommendation. The recall is a wonderful marketing opportunity for generics and house brands."