ADHD

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For those taking generic Adderall made by "Granules Pharmeceuticals"... (self.adhd)

submitted 10 months ago* (last edited 10 months ago) by toxic_cloud to c/adhd

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After being switched to a new manufacturer for my generic adderall XR this last month I have been feeling spaced out, unable to concentrate and fatigued. I also noticed other people having problems online the last few weeks.

And for anyone that wants to say "it's all in your head, generics are the same" this manufacturer had a citation from the FDA this December failing on multiple points of "quality control":

FDA Data Dashboard

The citation's details states the following (summarized because the text boxes are images and not actual text...):

The responsibilities/procedures are not in writing and fully followed

Separate/defined areas to prevent contamination are deficient regarding holding of rejected components, drug product containers and closures before disposition

Buildings used in manufacture and holding of drug products are not well maintained

Equipment used in manufacture, processing, packing or holding of drug products is not appropriate design to facilitate operations for intended use

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength quality or purity of drug product

Despite there being no guarantee drug is the proper dosage or even that the drug is pure and uncontaminated the FDA had taken no action or even warned them formally.

I literally do not understand how this drug is being sold right now.

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[–] [email protected] 24 points 10 months ago (1 children)

WOAAAHHH.

After being unable to source my Adderall for months I finally got it refilled. The same dose I've been taking for 20+ years. For some reason my body could not handle it, I was getting headaches and my pulse was racing and I was anxious. Which didn't make sense because I've previously had years without taking it and did not see these issues ever before (but I'm older now? Idk)

Anyway I asked for a dose change and we decreased by 5mg. Been better since.

Just looked at my bottle and the stuff I couldn't handle is made by Granules. 😮

[–] douglasg14b 1 points 9 months ago (1 children)

Please PLEASE report this in FDA Form 3500b

https://www.fda.gov/media/85598/download?attachment

This is how the FDA tracks this information and consumer reporting of abnormal reactions to drugs is critical for reporting and investigation.

[–] [email protected] 1 points 9 months ago

Thank you for sharing this! I didn't know this was an option - I was planning to bring it up with my psych at our next appointment. I'll look into reporting my experience.