On January 8, 2012, Novartis Consumer Health, Inc. recalled an extensive list of Excedrin, Bufferin, Gas-X and NoDoz products due to tablet mix-ups and chipped or broken tablets or gelcaps.
There is a possibility that prescription analgesics may also have been mixed with the recalled products. FDA has asked me to share the following warning:
To ensure continued patient safety and access to needed medicines, FDA and Endo Pharmaceuticals are providing instructions to patients and healthcare professionals on how to identify an incorrect pill in an opioid pain medicine prescription.
We are asking patients to check their medicines to look for any tablet of a different size, shape or color from their regular medicine. If they find any tablets that are different from the rest, they should stop taking their pain medicine and take their medicine to their pharmacy. We are telling patients to look carefully at all of the tablets in their pain medicine bottle. For any questions, patients can also contact Endo Pharmaceuticals at1-800-462-3636 or ask their pharmacist or doctor for additional help in identifying whether there are any problems with their medication. Endo Pharmaceuticals has posted pictures of their opioid analgesic tablets on their webpage to serve as a resource for tablet identification.”
This recall has been brewing stealthily and steadily since July 2011, when FDA issued a scathing report on the Quality Systems at Novartis Consumer’s Lincoln (Nebraska) plant.
The following list includes links to the current recall notice, prior recalls, and related articles. For a consolidated list of recalled items and of retailers who report having carried these items, please read: Novartis Gives Consumers Excedrin Headache.
Novartis Consumer Health Inc. Issues Voluntary Nationwide Recall Of Certain Over-The-Counter Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps (released January 8, 2012).
Novartis Animal Health “Dear Value Customer” letter, dated January 10, 2012
Novartis Animal Health “Dear Doctor” letter, dated January 25, 2012
Pedinol Pharmacal Inc. Announces Health Advisory for Gris-PEG (griseofulvin ultramicrosize) 125mg and 250mg (released February 2, 2012)
Excedrin, NoDoz, Bufferin, Gas-X Recalled Due to Potential Presence of Foreign Tablets or Chipped or Broken Pills (Connecticut Department of Consumer Protection. Posted January 9, 2012)
Food Safety Inspectors Conducting Quality Assurance Checks on Over-the-Counter Medications (Alabama Department of Agriculture and Industries. Posted January 9, 2012)
Human painkiller recall reportedly linked to Novartis veterinary drug shortage (AAHA Trends Today. January 11, 2012)
NOVARTIS GIVES CONSUMERS EXCEDRIN HEADACHE (updated January 17, 2012).
Novartis Product Recall: ‘What Took So Long?’ Consumer Blogger Asks (posted January 9, 2012 at Forbes.com)
Novartis Slow To Correct Quality Problems (posted January 12, 2012)
Excedrin Recall Spills Into Canada (posted January 15, 2012)
FDA Inspection Report Slams Novartis Inaction (posted January 30, 2012)
Novartis Fiasco Affects Pet Meds, Too (posted January 30, 2012)
Excedrin & Interceptor – Back By Mid-Year? (posted April 11, 2012)
Excedrin Return Still Months Away (posted April 24, 2012)
Good News/Bad News For Excedrin, Interceptor Users (posted July 19, 2012)