Cymbalta Recall Issued By FDA: Details

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Post on Oct 24, 2024

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Cymbalta Recall Issued by FDA: Details You Need to Know

The U.S. Food and Drug Administration (FDA) has issued a recall for Cymbalta (duloxetine hydrochloride), a medication used to treat depression, anxiety, and chronic pain. This recall affects specific lots of the drug due to a potential contamination issue. It is crucial for patients who have been prescribed Cymbalta to understand the details of the recall and what actions to take.

Why Was Cymbalta Recalled?

The FDA announced the recall after identifying a potential contamination with a substance called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. While NDMA is found in many common foods and water, the levels detected in some Cymbalta lots exceed the acceptable limits set by the FDA.

Which Lots Are Affected?

The recall specifically impacts certain lots of Cymbalta capsules manufactured by Eli Lilly and Company. The affected lots and their expiration dates can be found on the FDA website and on the official Eli Lilly recall notice.

If you have Cymbalta capsules, you should check the bottle carefully to see if your lot number is included in the recall. Do not take any Cymbalta capsules from an affected lot.

What Should Patients Do?

If you have a prescription for Cymbalta and your lot number is affected by the recall:

1. Contact your healthcare provider immediately. They can advise you on the best course of action, including alternative treatment options.
2. Do not discontinue taking your medication abruptly without consulting your doctor. Abruptly stopping Cymbalta can lead to withdrawal symptoms.
3. Return the recalled Cymbalta capsules to your pharmacy or dispose of them safely.

If you have any concerns about the recall or your medication, don't hesitate to reach out to your doctor, pharmacist, or the FDA.

Important Notes:

• This recall only affects certain lots of Cymbalta capsules. It does not apply to other formulations of the drug, such as the delayed-release capsules or the oral solution.
• The FDA is working closely with Eli Lilly to ensure the safety of patients. The company has stopped distributing the affected lots and is actively investigating the cause of the contamination.

Staying informed about medication recalls and taking appropriate action is crucial for maintaining your health. If you have any questions or concerns about the Cymbalta recall, contact your doctor or pharmacist for personalized guidance.