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 morphine sulfate prescription to see if it is involved in this FDA warning. This warning only applies to people taking morphine sulfate 15 mg or 30 mg tablets or morphine sulfate concentrate oral solution 20mg/ml, and morphine sulfate immediate release oral solution, 20mg/5ml made by Cody Laboratories, Inc., Glenmark Generics Inc., Lannett Company, Inc., Lehigh Valley Technologies Inc., Mallinckrodt Inc. Pharmaceuticals Group, or Physicians Total Care, Inc.

If you are taking morphine sulfate in the form of 15 mg or 30 mg tablets or a 20mg/ml or 20mg/5ml oral solution, 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 morphine sulfate, please follow up with your pharmacist or doctor.

FDA Warns Companies to Stop Producing Unapproved Narcotics

The FDA recently told several companies to stop producing morphine sulfate because their formulation of the product has not been approved by the FDA for marketing. The following formulations and manufacturers are affected by the FDA warning: Morphine Sulfate Tablets, 15 mg: Glenmark Generics Inc., Lehigh Valley Technologies Inc.

Morphine Sulfate Tablets, 30 mg: Glenmark Generics Inc., Lehigh Valley Technologies Inc, Physicians Total Care, Inc.

Morphine Sulfate Concentrate Oral Solution 20mg/ml: Cody Laboratories, Inc., Glenmark Generics Inc., Lannett Company, Inc., Lehigh Valley Technologies Inc., Mallinckrodt Inc. Pharmaceuticals Group

Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml: Glenmark Generics Inc.

Morphine sulfate is widely used to treat pain. Other manufacturers, such as Roxane, have FDA approved formulations of morphine sulfate solution and immediate release tablets. The FDA has determined that removal of unapproved products will not create a shortage of morphine sulfate for consumers.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-04-01
Last Updated: 2010-10-01

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