The Recall Desk
SevereFDA (Drugs)·D-530-2015·Announced 2015-04-29

Avanafil API Recalled for Potential Penicillin Cross Contamination

Attix Pharmaceuticals is recalling all lots of Avanafil active pharmaceutical ingredient distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury risks (such as penicillin cross-contamination which can cause severe allergic reactions) are categorized as Severe.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Avanafil active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product was packaged in varying grams or kilograms in bags or drums.

The recall is being conducted because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin.

The affected product was distributed nationwide to compounding pharmacies and research organizations. Compounding pharmacies and research organizations should stop using the affected lots and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Avanafil 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
Manufacturer
Attix Pharmaceuticals
Category
Drug — Active Pharmaceutical Ingredient
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots repackaged and distributed between 01/05/12 to 02/12/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 470 recalled by Attix Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 470 products in this recall →

Related recalls

Same manufacturer · Attix Pharmaceuticals

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Same hazard · penicillin cross contamination

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