Thousands of Duloxetine Bottles Recalled Over Safety Concerns

Towa Pharmaceutical is voluntarily recalling over 7,000 bottles of duloxetine due to the presence of a potential cancer-causing agent. The recall targets bottles with lot number 220128 and an expiration date of December 2024. Each bottle contains 500 delayed-release 20-milligram capsules. Duloxetine is the generic version of Cymbalta, a drug used to treat various conditions such as depression, anxiety, fibromyalgia, chronic muscle and joint pain, and nerve damage pain in diabetics.

The concern arises from the presence of nitrosamines, which the FDA has identified as potentially toxic if swallowed and suspected of causing cancer. The FDA has established limits on the allowable amounts of nitrosamine in medications. This recall is classified as a Class II recall, signifying a mid-level risk to health. In terms of safety, the FDA does not anticipate harm at low levels of nitrosamine exposure.

"Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer," – FDA

The FDA advises patients not to discontinue duloxetine use without consulting their healthcare provider. They stress that the potential consequences of stopping medication could outweigh the risks posed by nitrosamines.

"The risks of stopping their medicine may outweigh the potential risk of exposure to nitrosamines." – FDA

The FDA's Division of Drug Information is available for inquiries via email or phone. Additionally, their webpage titled "What to Know and Do About Possible Nitrosamines in Your Medication" offers detailed guidance on this matter. The FDA urges individuals to continue their prescribed medication until they have discussed any concerns with a healthcare professional.

Towa Pharmaceutical initiated this recall proactivity, underscoring its commitment to safety. The company aims to mitigate any potential health risks associated with the identified impurity.