Safety Alerts & Recalls

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Latest Alerts

FDA Warns Companies to Stop Making Unapproved Codeine Sulfate Tablets
The FDA recently told several companies to stop making and marketing codeine sulfate tablets because their formulation of the product has not been approved by the FDA. The following formulations and manufacturers are affected by the FDA warning: Codeine Sulfate Tablets, 30 mg, 60 mg - Lehigh Valley Technologies Inc., Allentown, PA Codeine Sulfate Tablets, 30 mg, 60 mg - Cerovene Inc., Valley Cottage, NY Codeine Sulfate Tablets, 30 mg - Dava International Inc., Fort Lee, NJ Codeine Sulfate Tablets, 30 mg, 60 mg - Glenmark Generics Inc., Mahwah, NJ Codeine is widely used to treat pain. Other manufacturers, such as Roxane Pharmaceuticals, have FDA approved formulations of codeine sulfate tablets and are able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets. For more information please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186418.htm
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Recall of Single Lot of Dr. Reddy's Citalopram 40 mg Tablets
Dr. Reddy's Laboratories Ltd. has recalled a single lot of Citalopram 40 mg tablets. The lot number involved in the recall is lot number C90995. These recalled tablets may be oversized and contain more drug than appropriate. This could result in patients receiving more than the expected dosage of this drug. Citalopram is used in the treatment of depression and is also known by the brand name Celexa. However, no other lot numbers, strengths, or brands of Citalopram were affected by this recall. For more information please visit: http://online.wsj.com/article/SB125430875357452197.html?mod=googlenews_wsj#articleTabs%3Darticle
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Date Published Title Drug Source
2009-10-14 FDA Warns Companies to Stop Making Unapproved Codeine Sulfate Tablets Codeine FDA
2009-09-30 Recall of Single Lot of Dr. Reddy's Citalopram 40 mg Tablets Citalopram Manufacturer
2009-09-30 Recall of Single Lot of Dr. Reddy's Fexofenadine 180 mg Tablets Fexofenadine Manufacturer
2009-09-30 Recall of Single Lot of Dr. Reddy's Pravastatin 10 mg Tablets Pravastatin Manufacturer
2009-09-30 Recall of Single Lot of Dr. Reddy's Risperidone (plain) 25 mg Tablets Risperidone Manufacturer
2009-09-28 FDA Early Communication About Ongoing Safety Review of Exjade Deferasirox FDA
2009-09-25 Voluntary Recall of Several Children's and Infants' Tylenol Products Acetaminophen Manufacturer
2009-09-25 Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors Oseltamivir FDA
2009-09-25 New Information About Reports of Acute Pancreatitis in Patients Using Sitagliptan (Januvia, Janumet) Sitagliptin FDA
2009-09-25 New Information About Reports of Acute Pancreatitis in Patients Using Sitagliptan (Januvia, Janumet) Metformin and Sitagliptin FDA
2009-09-17 FDA Requires Black Box Warning for Injection Form of Promethazine Promethazine FDA
2009-09-17 Update on Risk of Progressive Multifocal Leukoencephalopathy (PML) in Tysabri Patients Natalizumab FDA
2009-09-17 Several Lots of Albuterol Sulfate Inhalation Solution, 0.083% Reported Stolen Albuterol Manufacturer
2009-09-17 Three Lots of Ipratropium Bromide Inhalation Solution, 0.02% Reported Stolen Ipratropium Manufacturer
2009-09-16 Low-Dose Aspirin For Prevention Has Fewer Side Effects Than Higher Doses of Aspirin Clopidogrel MediGuard CRT
2009-09-16 Low-Dose Aspirin For Prevention Has Fewer Side Effects Than Higher Doses of Aspirin Ticlopidine MediGuard CRT
2009-09-16 Proton Pump Inhibitors (PPIs) in Healthy Patients May Cause Rebound Heartburn Symptoms Omeprazole MediGuard CRT
2009-09-16 Study Supports Link Between Pitavastatin MediGuard CRT
2009-09-14 Thiazolidinediones Associated with Increased Risk of Fractures Glimepiride and Rosiglitazone MediGuard CRT
2009-09-14 Important Information About Digoxin (Lanoxin) Digoxin MediGuard CRT
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