Safety Alerts & Recalls

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Latest Alerts

Recall on All ETHEX Brand Codeine with Guaifenesin
The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled ALL lots of ETHEX brand codeine phosphate/guaifenesin 10 mg tablets. These recalled tablets may have been manufactured under conditions that did not meet the current manufacturing standards called Good Manufacturing Practices (cGMPs). Some ETHEX products have recently had specific lots recalled due to defects found, including oversized tablets. ETHEX is now recalling all of their products to ensure that no other defective products remain available to patients. The ETHEX tablets and the NDC numbers involved in the recall are listed below. The NDC number is a product number that is sometimes listed on a prescription label. Codeine Phosphate/Guaifenesin Tablets, 10mg (NDC 58177-223-04) For more information, please visit: http://www.ethex.com/news/pressRelease012809.aspx
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FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers
The Food and Drug Administration announced it will require manufacturers of over-the-counter (OTC) pain relievers, fever reducers and cough and cold medications that contain acetaminophen (the active ingredient in Tylenol and many other brands) to revise their labeling to include warnings about potential safety risks, such as liver damage, associated with the use of these popular drugs. For more information, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149573.htm
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Date Published Title Drug Source
2009-02-01 Recall on All ETHEX Brand Codeine with Guaifenesin Codeine with Guaifenesin Manufacturer
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-07-31 New Safety Information for Colchicine Colchicine FDA
2010-10-01 Withdrawal of Unapproved Oral Colchicine Products Colchicine FDA
2009-12-14 Recall on Select Lots of Senna-Time and Senna-Time S Tablets FDA
2009-02-01 Recall on All ETHEX Brand Pangestyme Creon 20 Manufacturer
2011-04-25 Abbott Laboratories Recalls Several Lots of CREON (pancrelipase) Delayed Release Capsules, 6000 USP units Creon 20 FDA
2009-08-21 King Pharmaceuticals To Stop Making Intal Inhalers Cromolyn Sodium Manufacturer
2010-04-15 Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available Cromolyn Sodium FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Cyclobenzaprine Manufacturer
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Cyclosporine FDA
2012-02-26 FDA Issues Consumer Update about Grapefruit Juice and Medicine Interactions Cyclosporine FDA
2012-05-01 Apotex Inc. Recalls Single Lot of Cyclosporine Oral Solution, USP (modified), 100 mg/mL Cyclosporine FDA
2009-06-16 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Cylert FDA
2011-03-30 FDA Issues Safety Alert: Special Storage and Handling Requirements Must Be Followed for Pradaxa (Dabigatran Etexilate Mesylate) Capsules Dabigatran FDA
2011-12-08 FDA Evaluating Reports of Bleeding in Patients Taking Pradaxa Dabigatran FDA
2012-01-13 New Study Study Finds Small Increased Risk of Heart Attack in Patients Treated with Pradaxa Dabigatran MediGuard CRT
2012-11-06 FDA Reports Bleeding Risk With Pradaxa Similar to Warfarin Dabigatran FDA
2012-11-15 Boehringer Ingelheim Recalls Single Lot of Pradaxa 75 mg Capsules Dabigatran Manufacturer
2012-12-20 Pradaxa Contraindicated in Patients With Mechanical Heart Valves Dabigatran FDA
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