FDAClass IMarch 26, 2014

Clalis capsules recall

Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)

Why was Clalis capsules recalled?

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.

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
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Recalling firm
Fabscout Entertainment, Inc
Distribution
Nationwide and France
Recall date
March 26, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls