Another massive recall affects over the counter medications
Excedrin pulled off shelves after production issues mix medications.
Tuesday, January 17, 2012 - 14:00
As a retail manager I am always aware of inventory issues. I hate walking my store and seeing Swiss cheese shelves, plagued by patchy, out-of-stock conditions that give my store a poor appearance and even poorer sales.
This year I was getting kind of excited as, for the first time in nearly two years, my analgesics counter was full. Sure, I had a couple of holes, but it wasn't an entirely empty aisle with the same missing inventory items I'd been staring at for months. Tylenol was back on the shelves. Suffering from recall-itis, the popular product has been scarce for many months, prompting higher sales in generic medications, which have at times been just as difficult to come by as the brand name item.
But last week my short term elation came to a sudden halt when Excedrin announced its massive recall and wiped my counter free of product yet again.
What is it with pain medications? They seem to be causing more problems than they alleviate anymore.
This recall, issued on Jan. 9, 2012, stems from production issues at a Lincoln, Neb., Novartis manufacturing facility. While the company has since temporarily shut down production at this site, the problem seems to be with the possible mixing of medications, as the plant also manufactures prescription pain killers and other items sold under the name Endo Pharmaceuticals.
Dr. Edward Cox of the FDA stated that "Due to problems that occurred when these products were packaged and labeled at the site, it's possible that tablets from one product may have been retained in the packaging machinery and then may have carried over into the packaging of another product."
Scary. How many of us get up in the middle of the night and down a couple of pain relievers while stumbling around in the dark? Do we really look at them to inspect whether or not they are identical pills, or if something else was slipped into the container? What if those two different pills were a lethal combination, or caused an allergic reaction in someone? Scary, indeed.
But nothing has cleared the shelves in the past few years like Tylenol. The company made a phenomenal turn around after The Tylenol Crisis of 1982, when several people died from product tampering after using their products. What could have been the nuclear blast that destroyed the brand entirely became an event that cemented Tylenol as a household name, produced by an honest, trustworthy company intent upon delivering top notch product or no product at all.
Now McNeil Products, part of Johnson & Johnson, can go toe to toe with any Eagle Scout with their own sash of (de)merit badges. The company maintains a website strictly for information regarding the numerous recalls issued since January of 2010.
Now let's talk about scary. Many of the recalls for Tylenol have been due to the musky or moldy odor attributed to chemicals used on wooden pallets that carried their packaging materials, and even some grammatical problems on packages, when the word "not' was repeated during the directions. These issues are pretty staggering by themselves. But like Novartis, McNeill products has received some caustic reports from the FDA concerning their manufacturing conditions that are incredibly frightening.
In early 2010, the FDA released its findings from an inspection of the Johnson & Johnson manufacturing plant in Fort Washington, Penn., that produced the infant's and children's lines for Tylenol, Motrin, Zyrtec and Benadryl. This staggering report includes information that the company failed to keep proper documentation and training records, but also that the facility lacked good housekeeping standards, as equipment was found to be coated with dust in certain areas. Raw material was found to be tainted with a then-unknown bacteria, the plant had a hole in the ceiling, and even duct tape-covered pipes. While quality control standards were lacking, so were the follow-ups to customer complaints. According to documentation regarding these complaints, 46 were logged specifically about dark specks in the product from mid-2009 until the inspection, and no action was taken to look into the matter.
After taking a longer look into these recalls, I'm glad my shelves are empty, as I'd rather sell air than products like these.
Visit the Novartis website for further information about the Excedrin recall.