The Recall Desk
HighFDA (Drugs)·D-550-2015·Announced 2015-04-29

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

Attix Pharmaceuticals is recalling budesonide active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

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 High severity criteria for risk-of-harm products.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of budesonide 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 was initiated because the budesonide API was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin, which poses a risk to individuals with penicillin allergies.

The affected product was distributed nationwide to compounding pharmacies and research organizations. Consumers and healthcare providers should stop using the recalled budesonide API and contact their supplier or the recalling firm for instructions on return or disposal.

The recalled product

Product
Budesonide 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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