FDA Recalls Duloxetine (Cymbalta) Due to Impurities: What You Need to Know
The Food and Drug Administration (FDA) has issued a voluntary recall of Duloxetine (Cymbalta) capsules due to the presence of impurities that could pose a risk to patients. The recall affects specific lots of Duloxetine Hydrochloride Delayed-Release Capsules produced by Lundbeck LLC and Dr. Reddy's Laboratories Ltd.
This article will provide you with the crucial information about this recall, including:
- The specific lots affected by the recall.
- The potential risks associated with the contaminated medication.
- What steps you should take if you have been taking Duloxetine (Cymbalta).
Why is the FDA Recalling Duloxetine (Cymbalta)?
The FDA initiated the recall after discovering N-Nitrosodimethylamine (NDMA) in certain lots of Duloxetine (Cymbalta). NDMA is classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC). This means that exposure to NDMA can potentially increase the risk of developing cancer.
Which Lots of Duloxetine (Cymbalta) are Affected by the Recall?
This recall includes the following lots of Duloxetine Hydrochloride Delayed-Release Capsules:
- Lundbeck LLC:
- Lot Number: 2481222, 2481223, 2481224, 2481225, 2481226, 2481227, 2481228, 2481229, 2481230, 2481231, 2481232, 2481233, 2481234, 2481235, 2481236, 2481237, 2481238, 2481239, 2481240, 2481241, 2481242, 2481243, 2481244, 2481245, 2481246, 2481247, 2481248, 2481249, 2481250, 2481251, 2481252, 2481253, 2481254, 2481255, 2481256, 2481257, 2481258, 2481259, 2481260, 2481261, 2481262, 2481263, 2481264, 2481265, 2481266, 2481267, 2481268, 2481269, 2481270, 2481271, 2481272, 2481273, 2481274, 2481275, 2481276, 2481277, 2481278, 2481279, 2481280, 2481281, 2481282, 2481283, 2481284, 2481285, 2481286, 2481287, 2481288, 2481289, 2481290, 2481291, 2481292, 2481293, 2481294, 2481295, 2481296, 2481297, 2481298, 2481299, 2481300, 2481301, 2481302, 2481303, 2481304, 2481305, 2481306, 2481307, 2481308, 2481309, 2481310, 2481311, 2481312, 2481313, 2481314, 2481315, 2481316, 2481317, 2481318, 2481319, 2481320, 2481321, 2481322, 2481323, 2481324, 2481325, 2481326, 2481327, 2481328, 2481329, 2481330, 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