Let me just say at the outset that I generally pay extra to purchase brand name medications, prescription or over-the-counter (OTC), because of concerns I have about federal oversight of generic drug manufacturers.
On April 30, McNeil Consumer Products issued a voluntary recall of a litany of children’s cold products under the Tylenol, Motrin, Zyrtec and Benadryl brand names.
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States [in Fort Washington, PA] and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.
The complete product list can be found at the bottom of the press release (here) from which the above quote was derived.
McNeil noted that “some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.”
However, an ABC News story on the recall provides an FDA report (PDF) indicating that some of the remedies contained as-yet unidentified gram-negative bacteria.
Your humble blogger was contacted for this story and quoted therein but I had not known at the time of the bacterial contamination. All reports suggest that these problems are unlikely to present any risks to infants and children, pending identification of the bacteria, but this cannot be good – especially since this is the third recall by the manufacturer in the last eight months.
ABC News quoted a statement released Tuesday from Johnson & Johnson, the parent company of McNeil Consumer Healthcare:
“The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate,” the Johnson and Johnson statement read.
This recall is also yet another blow to the widely-held belief in the higher-quality of a brand name drug product over generic drugs, at least in the case of over-the-counter products:
“This recall provides compelling evidence that quality assurance is an issue for all drugmakers, and is not specific to generic products, as many have implied,” said Dr. Jerry Avorn, professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.
What struck me was the report from the Associated Press and the FDA’s own Q&A site that until these products are back on the market, parents use alternative products with the same ingredients on the labels – i.e., generic versions of the McNeil products – rather than trying to calculate how much of an adult-strength product to use in an infant or child.
I wonder how many parents might switch to the generics, see the incredible price savings, and switch permanently to one of these products.
Commenters at several of the news site also note that there has been much ado about quality control issues at drug plants outside the US; that excuse can’t be invoked in this case.