teva fluoxetine recall 2018

This recall is being carried out to the retail level due to a notification from the api manufacturer cadila concerning an elevated level of a residual solvent impurity in the api. A generic version of the antidepressants sarafem and prozac and teva is having to recall three lots of the product made by pliva.

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Teva pharmaceuticals usa inc.

Teva fluoxetine recall 2018. The national library of medicine nlm on the nih campus in bethesda maryland is the worlds largest biomedical library and the developer of electronic information services that delivers data to millions of scientists health professionals and members of the public around the globe every day. Fluoxetine capsules usp are indicated for the acute treatment of panic disorder with or without agoraphobia in adult patients see clinical studies 144. I recently switched to another manufacturer of 40mg fluoxetine from teva to par and the first two weeks on the new stuff was maddening to say the least.

This recall is being carried out due to out of specification test result for the lactoside impurity obtained during routine. In july 2011 fda began a pilot program to notify people of drug recalls before they are classified in an effort to expedite notifications of human drug product recalls to. Is voluntarily recalling all lots within expiry of fluoxetine tablets usp 10mg 30 count bottles only distributed under the teva pharmaceuticals label.

But business goes on and that includes the occasional recall. Teva recalls generic prozac made by croatian subsidiary pliva. Manufacturer teva pharmaceuticals has issued a voluntary nationwide recall of fluoxetine used to treat depression obsessive compulsive disorder and panic attacks.

Is voluntarily recalling the above lots of fluoxetine capsules usp 10 mg 20 mg distributed under the teva pharmaceuticals label. The effectiveness of fluoxetine capsules usp in long term use ie for more than 12 weeks has not been established in placebo controlled trials. Within that period i had about three days of intense anxiety butterflies and the feeling of an oxygen rush in my frontal lobes and one day with a severe migraine.

Is voluntarily recalling to the retail level all lots within expiry of fluoxetine tablets usp 10mg ndc 0093 7188 56 30 count bottles only distributed under the teva pharmaceuticals label. Teva pharmaceuticals usa inc. Dear member teva pharmaceuticals usa inc.

According to the fda one of the ingredients used to create the 10 mg fluoxetine tablet was not up to fda standards. Teva pharmaceutical has its hands full already with its 405 billion deal to buy actavis the generics business of what is now allergan. Why was fluoxetine recalled.

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