Over 7,000 bottles are involved in the official recall
The Food and Drug Administration (FDA) has recalled over 7,000 bottles of the popular antidepressant duloxetine sold under the brand name Cymbalta.
Used to treat depression, anxiety, and mood disorders, the agency found that the drug contained toxic levels of the chemical nitrosamine.
While the FDA says that the chemical isnt likely to cause harm in low levels, and consumers can handle low levels of the chemical for 70 years without health risks, it can increase the risk of cancer and become toxic to humans when ingested at higher than acceptable levels over an extended period of time.
FDA, in collaboration with regulatory counterparts around the world, has set internationally-recognized acceptable daily intake limits for nitrosamines, the agency wrote. If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate.
What consumers should know
Currently, this recall is classified as a Class II recall, which the FDA defines as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Towa Pharmaceutical Europe manufactured the contaminated pills, which have been distributed across the United States. In total, there are 7,107 bottles of duloxetine that have higher than normal levels of nitrosamines.
The affected medications will be 20 mg pills that come in bottles of 500 pills, have an expiration date of December 2024, and a lot number of 220128.
While this is a voluntary recall, the FDA hasnt shared any specific guidance on how consumers should proceed. However, if your medication is part of the recall, its best to check with your health care provider on proper next steps.
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Posted: 2024-10-24 18:39:16