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Message 1
From: FDA MedWatch
Date: Jan, Mon 9 2012 10:53 -0500 (EST)
Subject: FDA MedWatch - Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

including Excedrin, NoDoz, Bufferin, Gas-X Prevention

AUDIENCE: Consumer, Pharmacy
ISSUE: Novartis Consumer Health Inc. is voluntarily recalling all lots of over-the-counter products Exedrin, Bufferin, Gas-X Prevention and NoDoz. Reports were received of chipped and broken pills and inconsistent bottle packaging clearance practices at the Lincoln, Nebraska facility, which could result in the bottles containing foreign tablets, caplets, or capsules.
Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.
BACKGROUND: This voluntary recall pertains to all lots of select bottle packaging configurations from retailers of Excedrin and Nodoz products (expiry dates of December 20, 2014 or earlier), and Bufferin and Gax-X Products (expiry dates of December 20, 2013 or earlier), in the United States.
RECOMMENDATION: All of the pills in the bottle should look the same. If patients find a pill that is different in shape, size, color, or markings, they should bring their medicine bottle to their pharmacist and not take any of those pills.
Consumers that have the product(s) being recalled should stop using them and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the company Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm286265.htm

Message 2
From: FDA MedWatch
Date: Jan, Mon 9 2012 11:13 -0500 (EST)
Subject: FDA MedWatch - Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Including the following products:

Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
Opana (oxymorphone hydrochloride) CII
Oxymorphone hydrochloride Tablets CII
PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
MORPHINE SULFATE Extended-Release Tablets CII
ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

AUDIENCE: Pharmacy, Consumers
ISSUE: FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product.
BACKGROUND: Opiates are potent medications used to alleviate pain and are available only by prescription. Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009; all three were detected by pharmacists. Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.
RECOMMENDATION: FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the medWatch safety alert, including a link to the FDA Public Health Advisory, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm286280.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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