The Recall Desk
HighFDA (Drugs)·D-741-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Ketoconazole API Due to Penicillin Cross-Contamination Risk

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk allergen (penicillin) cross-contamination hazard where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Ketoconazole 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 and distributed nationwide to compounding pharmacies and research organizations.

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, which poses a risk to individuals with penicillin allergies.

Compounding pharmacies and research organizations that received these products should stop using them and contact the recalling firm for further instructions. Consumers should not use any Ketoconazole products derived from these specific lots if they have a known penicillin allergy.

The recalled product

Product
Ketoconazole 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 · allergen penicillin

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