The Recall Desk
SevereFDA (Drugs)·D-893-2015·Announced 2015-04-29

Sildenafil Citrate Recalled for Potential Penicillin Cross Contamination

Attix Pharmaceuticals is recalling Sildenafil Citrate active pharmaceutical ingredient due to potential penicillin cross contamination during repackaging.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of severe allergic reactions from penicillin cross-contamination.

Plain-English summary

Attix Pharmaceuticals is recalling Sildenafil Citrate active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all lots repackaged and distributed between January 5, 2012, and February 12, 2015. The total quantity involved is 126,510 grams.

The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a potential for cross contamination with penicillin. The affected product was distributed nationwide to compounding pharmacies and research organizations.

Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on return or disposal. Consumers should not use Sildenafil Citrate products from this source if they are unsure of the origin.

The recalled product

Product
Sildenafil Citrate 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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