Novartis Recall

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On January 31, 2013, Novartis Consumer Health, Inc. (NCH) voluntarily recalled some Theraflu® and Triaminic® syrups because of problems with the child-safety caps that made them too easy for children to open. There was no problem with the medication itself.[1]

On January 8, 2012, Novartis issued a recall of several over-the-counter products in the United States. The recall resulted from an investigation that had been triggered by consumer complaints about broken and chipped pills. Upon investigating their facility at Lincoln, Nebraska, where these products were produced, it was determined that faults in the bottle packaging line could result in products containing damaged tablets or capsules, as well as the mixing of stray tablets from other Novartis products.[2] The FDA warned that the mix-up could also involve several powerful opiods, including Percocet®, Endocet®, Opana®, and Zydone®, which are manufactured at the same facility. The opiod drugs were not recalled.[3]

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FreeExcedrin.jpg
Flickr: Earthman
Date of latest recall January 31, 2013
Novartis headquarters Basel, Switzerland[4]
Novartis recall phone (US) 888-477-2403
FDA MedWatch 800-FDA-0178
Recalled products include OTC drugs and vaccines[5]
Disclaimer The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
Author Julie Clark
 
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Contents

Theraflu Shortage

Novartis shut down the plant in Lincoln, Nebraska, where the mix up occurred.[6] While not implicated in the recall, the plant shut down affected the supply of all medications produced at the facility. As a result, although products such as Theraflu®, Triaminic®, Lamisil®, Maalox®, and Benefiber® were not subject to the recall, supplies were interrupted.[7] The plant resumed limited production in September 2012, but Theraflu® is still off the shelves in many areas.[8]

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Novartis Recall Timeline

January 31, 2013: NCH recalled Triaminic® Syrups and Theraflu Warming Relief® Syrups after the US Consumer Product Safety Commission reported that defective child-safety caps had resulted in several children overdosing on the medications.

October 26, 2012: Novartis Consumer Health, Inc. recalled some batches of flu shots in Germany as ordered by the German government. There were no instances of illness from the recalled vaccines, but they were recalled as a precautionary measure after Novartis reported small foreign particles during the manufacturing process. The vaccines Begripal and Fluad® were affected; the vaccine Optaflu® was not. Italy and Switzerland also banned certain Novartis flu vaccines for the same reason. These include Fluad®, Begripal, Influpozzi Adiuvato and Influpozzi Subunita. Novartis claims that the particles do not cause any risk, but sometimes occur in manufacturing. The U.S. was not affected by any of these recalls.[9]

January 8, 2012: Novartis recalled Bufferin® products with an expiration date of December 20, 2013 or earlier, including Bufferin® Extra Strength Tablets, Bufferin® Low Dose Tablets, and Bufferin® Regular Strength Tablets. Excedrin® products with an expiration date of December 20, 2014 or earlier, were recalled, including, Excedrin® Extra Strength Caplets, Excedrin® Extra Strength Express Gel Caplets, Excedrin® Extra Strength Gel Caplets, Excedrin® Extra Strength Tablets, Excedrin® Back & Body Caplets, Excedrin® Sinus Headache Caplets, Excedrin® Migraine Caplets, Excedrin® Migraine Gel Tablets, Excedrin® Migraine Tablets, Excedrin® Menstrual Complete Express Gel Caplets, Excedrin PM® Caplets, Excedrin PM® Express Gel Caplets, Excedrin PM® Tablets, and Excedrin® Tension Headache Caplets. All lots of all Gas-X Prevention® products with an expiration date of December 20, 2013 or earlier, and all No-Doz® products (all lots) with an expiration date of December 20, 2014 or earlier were subject to the recall.

About Novartis

Novartis Consumer Health, Inc. is a company of the Novartis Group created on March 7, 1996, with the merger of two chemical/life sciences companies in Switzerland, Ciba-Geigy and Sandoz. Novartis’ core business is pharmaceuticals, vaccines, consumer health, generics, eye care, and animal health.[10] The company is headquartered in Basel, Switzerland. Some of the company's brands include Exelon®, Gilenya®, and Lamisil®.[5]


Also See: Drug Recalls, FDA, Novartis Patient Assistance Programs, Johnson and Johnson Recall, Benadryl Recall, Birth Control Recall

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References

  1. http://www.novartisotc.com/recall_theraflu_triaminic.html
  2. http://www.novartis.com/newsroom/media-releases/en/2012/1575836.shtml
  3. http://abcnews.go.com/Business/wireStory/fda-warns-pill-mix-endo-painkillers-15321522#.TwumfvnwuHc
  4. http://www.novartis.com/
  5. 5.0 5.1 http://www.novartis.com/products/index.shtml
  6. http://www.novartis.com/newsroom/media-releases/en/2012/1575836.shtml
  7. http://www.forbes.com/sites/edsilverman/2012/01/10/254/
  8. http://journalstar.com/business/local/some-drugs-again-being-produced-at-novartis/article_3902f46b-15b7-51ca-b39d-924d5bbbd928.html
  9. http://www.foxnews.com/health/2012/10/26/germany-orders-recall-some-novartis-flu-shots/
  10. http://www.us.novartis.com/about-novartis/index.shtml