FDAClass IJuly 13, 2016

Oasis Capsules recall

Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043

Why was Oasis Capsules recalled?

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

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?

All lots

Product
Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043
Recalling firm
Bee Extremely Amazed LLC
Quantity
581 bottles
Distribution
Nationwide
Recall date
July 13, 2016
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls