FDAClass IIApril 29, 2015

Vardenafil HCl Trihydrate active pharmaceutical recall: Contamination

Vardenafil HCl Trihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

Why was Vardenafil HCl Trihydrate active pharmaceutical recalled?

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

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 repackaged and distributed between 01/05/12 to 02/12/15

Product
Vardenafil HCl Trihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Recalling firm
Attix Pharmaceuticals
Quantity
16775 grams
Distribution
Nationwide to compounding pharmacies and research organizations.
Recall date
April 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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