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MEETINGS / EVENTS

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May 05 - 07 2014, 12:00 AM - 12:00 AM

2014 ASA Legislative Conference

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FDA MEDWATCH ALERTS

March 28, 2014

FDA Update on the Shortage of Normal Saline

Summary:

FDA Update on the Shortage of Normal Saline

March 18, 2014

FDA MedWatch - Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

Summary:

Merit Medical Systems Custom Procedural Trays Kits Recall Particulates Found in Hospira Lidocaine

March 18, 2014

McKesson Technologies Anesthesia Care: Recall - Patient Case Data May Not Match Patient Data

Summary:

McKesson Technologies Anesthesia Care Recall Patient Case Data May Not Match Patient Data

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ASA FEATURED PRODUCT

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Self Education and Evaluation (SEE) Program

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Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets

Monday, June 27, 2011

ISSUE : Endo Pharmaceuticals and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg  because some bottles may contain different strength tablets, resulting in  patients taking more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.

BACKGROUND : The affected lots were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers who are located in the following states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO, PA, FL and TN. These wholesalers may further distribute to other retailers and wholesalers nationwide. Lot numbers can be found on the side of the manufacturer’s bottle. Tablet descriptions and photographs are provided in the firm's press release.

RECOMMENDATION : Consumers who have the affected product should stop using the product and contact Endo’s agent Stericycle at 1-866-723-2681 for return of the product.

Health care 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 press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm260979.htm

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