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Medicare AssuredSM Drug Recalls
Information on Drug Recall, Market Withdrawals, and Safety Alerts for Providers
Gateway HealthSM is committed to giving health care providers important information to help you coordinate safe and quality drug therapy for your patients. To support you in these efforts, we are providing you with tools to keep you informed of drug recalls, market withdrawals, and safety alerts.
The Food and Drug Administration (FDA) posts information on drug products that have been recalled due to manufacturing problems and/or safety concerns. For up-to-date information on drug recalls, market withdrawals, and safety alerts, visit the FDA website at: http://www.fda.gov/Safety/MedWatch/default.htm.
In addition, the FDA publishes its weekly Drug Enforcement Report which contains information on actions taken in connection with agency regulatory activities. The Drug Enforcement Report can be accessed via the following link: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.
Drug Recalls have three categories according to the level of hazard involved. Recalls may be conducted voluntarily by a manufacturer, by FDA request, or by FDA order under statutory authority.
- Class I recall: a situation in which use of or exposure to a violative product will cause serious adverse health consequences or death.
- Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
How to Report an Adverse Event to the FDA:
By phone: 1-800-332-1088
By Fax: 1-800-FDA-0178
Online: Reporting forms can be accessed on the FDA website at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Drug Recalls and Withdrawals
Abbott Diabetes Care voluntarily recalls FreeStyle InsuLinx Blood Glucose Meters
Date received: 4/15/2013
Abbott Diabetes Care is recalling FreeStyle InsuLinx Blood Glucose Meters because the company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. For example, at a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL – 1024 mg/dL = 42 mg/dL). Patients who are using the FreeStyle InsuLinx Meter should take one of the following actions to address this issue with their meter:
- Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. The software update will allow customers to maintain settings and historical data on their meter.
- Customers can contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of their FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send meters to customers immediately upon request.
The LifeScan unit of Johnson and Johnson voluntarily recalls all One Touch Verio IQ Glucose Meters
Date received: 3/25/2013
The LifeScan unit of Johnson and Johnson is voluntarily recalling its One Touch Verio IQ Glucose Meters because the meter is failing to display the standard warning message “Extreme high glucose above 600mg/dL” and instead shuts off. LifeScan is advising clinicians to stop distributing One Touch Verio IQ meters to patients and call 1-877-644-0004 to arrange a pickup of samples.
Reckitt Benckiser voluntarily discontinues the sale of Suboxone tablets
Date received: 9/25/2012
Reckitt Benckiser announced on September 25, 2012 that they have voluntarily decided to stop selling Suboxone tablets after receiving a study that found the pills were more likely to be accidentally taken by young children than Suboxone film. The company has stated that Suboxone tablets can still be dispensed and ordered until the customer is switched to another alternative or there is no longer a supply of medication available in the marketplace.
FDA issues a market withdrawal of ALL propoxyphene-containing products-Risk of Cardiac Toxicity
Date received 11/19/10
FDA recommends all healthcare professionals stop prescribing and dispensing propoxyphene-containing products due to new data showing that the drug can cause serious toxicity to the heart, such as prolonged PR interval, widened QRS complex and prolonged QT interval, even when used at therapeutic doses.
Questions about this recall, call the FDA at 1-800-332-1088.
Octapharma USA, Inc. issues a voluntary market withdrawal of ALL lots of Octagam (Immune Globulin Intravenous (Human)) 5% Liquid Preparation
Date received 9/29/10
Octapharma USA, Inc. is initiating a voluntary market withdrawal of ALL lots of Octagam 5% Liquid Preparation until a root cause of the previously reported thromboembolic events can be determined and the problem corrected.
If you have any questions about this market withdrawal you should contact Octapharma’s customer service department at 866-766-4860.
Endo Pharmaceuticals will discontinue Moban tablets all strengths (5mg, 10mg, 25mg, and 50mg)
Date Received 1/21/2010
Endo Pharmaceuticals will discontinue the sale and distribution of all available strengths of Moban® (molindone) Tablets. This action is not the result of any issues with safety or efficacy. Endo has been unable to obtain an alternate supplier of molindone hydrochloride after the current supplier notified Endo of their intent to discontinue manufacture of molindone hydrochloride. Supplies are expected to be depleted by June 30, 2010.