Yesterday, two more shoes dropped in the latest product scare that bears the Tylenol name.
Shoe No. 1: McNeil Consumer Healthcare said it had temporarily shut down its production plant in Fort Washington, Pa., where it makes dozens of different liquid versions of four brand-name medicines - Tylenol, Motrin, Benadryl and Zyrtec - designed for babies and kids.
Shoe No. 2: The FDA released an inspection report that pretty well explained why.
If you're a parent, you know those children's drugs. They're the medicines you buy - and pay twice as much for - because you trust the brand-name version more than the generic. I know I've done that, even though I happily buy generics of the adult equivalents and prescription drugs. Who wants to take chances with our precious kids?
McNeil and its parent company, Johnson & Johnson, are in circle-the-wagons mode when it comes to the media, but they have been insistent that they are cooperating fully with the regulators and don't challenge the FDA's preliminary findings. One FDA official told reporters that the inspection found "numerous deficiencies in the ways in which McNeil products were manufactured and in which the manufacturing process for those products was controlled."
You can see our story today here. Just to give you its flavor, one of the FDA's 20 observations said: "There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess."
- McNeil announced a voluntary recall of all unexpired versions of these four products - all liquid or drop versions of Tylenol, Motrin, Benadryl and Zyrtec. You can get McNeil's refund instructions and other information at its special site, McNeilProductRecall.com, or you can take the package back to your pharmacy. At least some, including CVS, say they'll give you a refund or a store credit.
- Don't use the products. There are generic versions available of all of them. You can read my Q&A from Tuesday's paper here, the FDA's announcement here, and McNeil's FAQs here. If you want to see the FDA's inspection report, click here.
- Stay tuned.