Safety Alerts & Recalls

What does this mean?

Although this is not a recall alert, the safety of unapproved drugs is unknown and you should review your codeine prescription to see if is involved in this FDA warning. This warning only applies to people taking codeine sulfate tablets, 30 mg and 60 mg made by Lehigh Valley Technologies Inc., Cerovene Inc., Dava International Inc., and Glenmark Generics Inc. If you are taking codeine sulfate 30 mg or 60 mg tablets, look at your prescription bottle to see if it was made by one of the companies involved in the warning. The manufacturer is often listed on the prescription label. If you think you might be taking an unapproved product or if you are not sure, please bring your bottle to your pharmacy for them to examine and possibly replace.

If you have any questions about this safety alert or your use of codeine, please follow up with your pharmacist or doctor.

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.

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Source: FDA
Publication Date: 2009-10-14
Last Updated: 2009-12-05

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