I got this in an email today
Safety Alert: Voluntary Recall and Supply Reduction
January 9, 2012
Novartis Voluntarily Recalls Some Over-the-Counter Medications, Issues Temporary Suspension of Manufacturing Operations
Novartis has recalled 1,645 lots of over-the-counter medications, including Excedrin, Bufferin, NoDoz and Gas-X, following hundreds of complaints of broken and chipped pills and inconsistent bottle packaging that could cause pills to be mixed up. These include certain bottles of headache medicine Excedrin and caffeine caplets NoDoz with expiration dates of Dec. 20, 2014. The company is also recalling some packages of pain medicine Bufferin and stomach medicine Gas-X with expiration dates of Dec. 20, 2013, or earlier.
For more information, individuals can call the company at (888) 477-2403, Monday through Friday, 9 a.m. to 8 p.m. EST.
Related to this recall, Endo Pharmaceuticals, Inc., announced that a temporary shut-down of Novartis Consumer Health Inc.'s Lincoln, Neb., manufacturing facility was required, where some of Endo’s products are also packaged. The company says pharmacies may experience a short-term shortage of certain opioid analgesics.
These include:
Oxymorphone hydrochloride extended-release tablets (Opana ER)
Oxymorphone hydrochloride (Opana)
Oxymorphone hydrochloride tablets
Oxycodone hydrochloride and acetaminophen tablets (Percocet)
Oxycodone hydrochloride and aspirin tablets (Percodan)
Oxycodone hydrochloride and acetaminophen tablets (Endocet)
Oxycodone hydrochloride and aspirin tablets (Endodan)
Morphine sulfate extended-release tablets
Hydrocodone bitartrate/acetaminophen tablets (Zydone)
In addition, the Food and Drug Administration (FDA) issued a warning to consumers, health care professionals and patients today that there is a potential for mix-up between the prescription opioid medications and common over-the-counter medications packaged this plant. Endo is working closely with the FDA and Novartis to minimize disruptions, upgrade quality standards and promptly resume production of these products at the Lincoln facility.
FDA advises health care professionals and their patients to examine opiate medicines made by Endo in their possession and verify that all tablets are the same. For any questions, the public may call Endo Pharmaceuticals' call center at (800) 462-3636.
Health care professionals and individuals with prescription problems are urged 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 this 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
Safety Alert: Voluntary Recall and Supply Reduction
January 9, 2012
Novartis Voluntarily Recalls Some Over-the-Counter Medications, Issues Temporary Suspension of Manufacturing Operations
Novartis has recalled 1,645 lots of over-the-counter medications, including Excedrin, Bufferin, NoDoz and Gas-X, following hundreds of complaints of broken and chipped pills and inconsistent bottle packaging that could cause pills to be mixed up. These include certain bottles of headache medicine Excedrin and caffeine caplets NoDoz with expiration dates of Dec. 20, 2014. The company is also recalling some packages of pain medicine Bufferin and stomach medicine Gas-X with expiration dates of Dec. 20, 2013, or earlier.
For more information, individuals can call the company at (888) 477-2403, Monday through Friday, 9 a.m. to 8 p.m. EST.
Related to this recall, Endo Pharmaceuticals, Inc., announced that a temporary shut-down of Novartis Consumer Health Inc.'s Lincoln, Neb., manufacturing facility was required, where some of Endo’s products are also packaged. The company says pharmacies may experience a short-term shortage of certain opioid analgesics.
These include:
Oxymorphone hydrochloride extended-release tablets (Opana ER)
Oxymorphone hydrochloride (Opana)
Oxymorphone hydrochloride tablets
Oxycodone hydrochloride and acetaminophen tablets (Percocet)
Oxycodone hydrochloride and aspirin tablets (Percodan)
Oxycodone hydrochloride and acetaminophen tablets (Endocet)
Oxycodone hydrochloride and aspirin tablets (Endodan)
Morphine sulfate extended-release tablets
Hydrocodone bitartrate/acetaminophen tablets (Zydone)
In addition, the Food and Drug Administration (FDA) issued a warning to consumers, health care professionals and patients today that there is a potential for mix-up between the prescription opioid medications and common over-the-counter medications packaged this plant. Endo is working closely with the FDA and Novartis to minimize disruptions, upgrade quality standards and promptly resume production of these products at the Lincoln facility.
FDA advises health care professionals and their patients to examine opiate medicines made by Endo in their possession and verify that all tablets are the same. For any questions, the public may call Endo Pharmaceuticals' call center at (800) 462-3636.
Health care professionals and individuals with prescription problems are urged 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 this 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
