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FDA Issues Reminder Warning for Combination Medicines Containing Acetaminophen
The Food and Drug Administration (FDA) is reminding healthcare professionals to stop prescribing, and pharmacists to stop dispensing, prescription combination drug products that contain high doses of acetaminophen. Prescription products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit are no longer considered safe by FDA. These products have been voluntarily withdrawn by the manufacturers at the FDA’s request to protect consumers from the risk of severe liver damage that can result from taking too much acetaminophen. Although these products have been voluntarily withdrawn from the market, some pharmacies and wholesalers may continue to make them available for dispensing to patients despite the FDA’s actions. The FDA is asking pharmacists and wholesalers to return these products to the respective manufacturer. Acetaminophen is a pain reliever and fever reducer available in several different formulations, combinations, and brand names. Some common prescription combination medicines containing acetaminophen include: oxycodone and acetaminophen (Percocet®, Roxicet™, Roxilox®, Tylox®), hydrocodone and acetaminophen (Anexsia®, Lortab®, Norco®, Zydone®), codeine and acetaminophen (Tylenol w/Codeine No. 1, Tylenol w/Codeine No. 2, Tylenol w/Codeine No. 3), and tramadol with acetaminophen (Ultracet®). Several migraine medicines such as Esgic-Plus®, Butapap, Fioricet®, and Fioricet® with Codeine also contain acetaminophen. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm394916.htm
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FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips
The Food and Drug Administration (FDA) is advising people with diabetes to stop using GenStrip™ Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. GenStrip™ Blood Glucose Test Strips are "third-party" blood glucose monitoring test strips sold by Shasta Technologies LLC. Shasta’s GenStrip™ test strips are advertised for use with the LifeScan OneTouch® family of glucose meters, including the models Ultra®, Ultra® 2, and UltraMini®. During a recent inspection of Shasta Technologies LLC, the FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels. The affected test strips have been manufactured and distributed since March 2013 and are available through online retailers and retail pharmacies. The blood glucose test strips are used in the home and in healthcare facilities to measure blood glucose levels in diabetes care and management. People with diabetes carefully monitor their blood glucose levels and require urgent treatment for low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). An inaccurate blood glucose reading could lead to inappropriate or delayed treatment that could significantly harm a patient. For more information and to view a photo of the GenStrip™ packaging, please visit: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm395180.htm
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Date Published Title Drug Source
2014-05-01 FDA Issues Reminder Warning for Combination Medicines Containing Acetaminophen Acetaminophen with Oxycodone FDA
2014-05-01 FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips FDA
2014-05-01 FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips Tolazamide FDA
2014-04-01 FDA Clarifies Warning About Use of Revatio for Pulmonary Arterial Hypertension in Children Sildenafil FDA
2014-03-31 GlaxoSmithKline Reports Product Tampering With alli® Orlistat Manufacturer
2014-03-07 Pfizer Recalls Some Lots of Antidepressant Effexor Venlafaxine Manufacturer
2014-02-20 Manufacturer Recalls Specific Lots of L-Citrulline After Reports of Adverse Events Citrulline FDA
2014-02-20 Ben Venue Laboratories, Inc. Recalls Single Lot of Acetylcysteine Solution 10%, 30 mL Vial Acetylcysteine FDA
2014-02-12 FDA Reviewing Saxagliptin (Onglyza or Kombiglyze XR) Trial Data for Possible Heart Failure Risk Saxagliptin FDA
2014-02-04 NewMarket Health Products, LLC Recalls Single Lots of NorthStar Arthritis Relief Cream Menthol FDA
2014-02-04 Greenstone LLC Recalls Single Lot of Nifedipine, Extended-Release 90 mg Tablets Nifedipine FDA
2014-02-03 FDA to Evaluate Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products Methyltestosterone FDA
2014-01-17 Some Over-the-Counter Wart Removers Are Flammable Dimethyl Ether and Propane FDA
2014-01-15 Tandem Diabetes Care Issues Recall for Insulin Cartridges Used with t:slim Insulin Pump Insulin FDA
2014-01-15 Merck Recalls All Lots of Liptruzet Atorvastatin and Ezetimibe Manufacturer
2014-01-15 New FDA Recommendations Aimed at Cutting Risks from Acetaminophen FDA
2014-01-10 Nipro Recalls TRUEtrack and TRUEbalance Glucose Meters Insulin Aspart FDA
2014-01-08 FDA Warns of Possible Harm From Exceeding Dose of Over-the-Counter Enemas and Oral Solutions Used to Treat Constipation FDA
2014-01-02 FDA Requires New Safety Measures for Iclusig (Ponatinib) Before It Can Return to Market Ponatinib FDA
2013-12-17 FDA Warns of Rare Risk of Priapism Associated with Methylphenidate Products Dexmethylphenidate FDA
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