Why was fluoxetine recalled?
According to the FDA, one of the ingredients used to create the 10 mg fluoxetine tablet was not up to FDA standards. While the use of the product is not likely to have significant adverse health consequences, Teva has pulled certain lots of fluoxetine until they are up to FDA regulations.
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Which fluoxetine products were recalled?
According to Teva, the affected products were shipped from March 24th, 2016 to January 4th, 2018. The recall will affect the following:
- Drug: Fluoxetine 10 mg tablets
- Manufacturer: Teva Pharmaceuticals
- National Drug Code (NDC): 00093-7188-56
What has been done to alert those who may be affected?
Teva Pharmaceuticals is notifying distributors and customers by letter and is arranging for return of all recalled products.
What should I do if I think I may have the affected product?
You should contact your physician or healthcare provider if you have experienced any problems that you think may be related to taking this medication. You should not stop taking fluoxetine without talking to your prescribing physician.
Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations.