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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