By: Aleena Chacko, Long Island University Pharm.D. Candidate c/o 2013
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Established in 1996, Novartis International AG is a multinational pharmaceutical company based in Switzerland. On January 8, 2012, Novartis issued a recall on some popular over the counter (OTC) medications in the United States (U.S.) over concerns about broken or incorrect tablets ending up in these medication bottles. The questionable drugs were Excedrin® and Bufferin®. However, Novartis Consumer Health stated that the recall, as a precautionary measure, also applies to bottled versions of Gas-X® and NoDoz®. With this, Novartis decided to suspend production at its plant in Lincoln, Nebraska for “maintenance and other improvement activities.”
Some bottles of headache medicine (Excedrin®) and caffeine caplets (NoDoz®) with expiration dates of December 20, 2014 or earlier are subject to recall. Additionally, some packages of pain medicine (Bufferin®) and stomach medicine (Gas-X®) with expiration dates of December 20, 2013 or earlier are also affected. Novartis said mixing of different products in the same bottle could result in patients taking an incorrect product (stray pill), receiving a higher/lower strength than intended, or perhaps receiving an unintended ingredient that could result in overdose or an allergic reaction. Novartis became aware of this potential problem during an internal review and complaints that identified issues such as broken gelcaps, chipped tablets, and inconsistent bottle packaging line clearance practices (where a potential for a tablet mix up was not ruled-out). The Swiss pharmaceutical company is working with the Food and Drug Administration (FDA) during the voluntary recall that affects U.S. retailers to make sure that patients did not take any pills that they might be allergic to or that might be dangerous when mixed with other medications. However, Novartis also stated that there have not been any complaints or consumer-reported adverse events.
On the other hand, the FDA is advising healthcare professionals and patients to examine the opiate products that Novartis makes for Endo Pharmaceuticals to make sure that all the tablets are the same. It issued a warning for the following Controlled Substance Schedule II (C-II) prescription products:
- Opana ER (oxymorphone hydrochloride) ER tablets
- Opana (oxymorphone hydrochloride) tablets
- Oxymorphone hydrochloride tablets
- Percocet (oxycodone hydrochloride and acetaminophen) tablets
- Percodan (oxycodone hydrochloride and aspirin) tablets
- Endocet (oxycodone hydrochloride and acetaminophen) tablets
- Endodan (oxycodone hydrochloride and aspirin) tablets
- Morphine sulfate ER tablets
- Zydone (hydrocodone bitartrate/acetaminophen tablets)
However, the recall did not end there. On January 13, 2012, Novartis AG expanded its Excedrin® recall to the Canadian health authorities. Health Canada said the Swiss company is recalling all lots of Excedrin® Extra Strength Caplets and Excedrin® Tension Headache caplets with expiration dates of December 20, 2014 or earlier. The medication is being recalled for the same reason as above. Health Canada will advise Canadian citizens if other details emerge.
As previously mentioned, Novartis has voluntarily suspended operations and shipments from its Lincoln, Nebraska, facility to rectify the problems at the site. This Swiss pharmaceutical company states that the recalls and factory repairs will cost around $120 million. On January 16, shares of Novartis fell 95 cents to $55.78, and may continue to decrease in value within the next couple of days.
SOURCES:
- Drug Topics. Novartis recalls OTC products; FDA issues warning about company’s opiate products. Available online: http://drugtopics.modernmedicine.com/drugtopics/Top+News/Novartis-recalls-OTC-products-FDA-issues-warning-a/ArticleStandard/Article/detail/755520?contextCategoryId=47443
- MarketWatch. Novartis Recall of Excedrin Products Extends to Canada. Available online: http://www.marketwatch.com/story/novartis-recall-of-excedrin-products-extends-to-canada-2012-01-13
- Thomson Reuters Foundation. Novartis issues recall on Excedrin, Bufferin. Available online: http://www.trust.org/alertnet/news/novartis-issues-recall-on-excedrin-bufferin/
