FDAClass IINovember 27, 2019

Mello-Tonin recall: CGMP Deviations

Mello-Tonin 2 fl. oz. glass bottle, SKU: 100-5C

Why was Mello-Tonin recalled?

Products do not conform to Dietary Supplement CGMP regulations.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

180209-BSC2354, 170801-BSC2354

Product
Mello-Tonin 2 fl. oz. glass bottle, SKU: 100-5C
Recalling firm
Basic Reset Inc.
Quantity
N/A
Distribution
Product was shipped to all 50 states. Product was shipped to the following foreign consignees: Canada, Nigeria, U.K., Australia, Israel, Puerto Rico, Virgin Islands, Hungary, UAE, Mexico, Philippines, Greece, and Puerto Rico.
Recall date
November 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (food)
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