The Recall Desk
SevereFDA (Drugs)·D-676-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Floxuridine Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling all lots of Floxuridine 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. According to the rubric, FDA Class II recalls involving significant injury risks or hospitalization reports are rated as Severe (4). While no specific injuries are reported in the text, the potential for penicillin cross-contamination in a pharmaceutical context is a significant safety hazard.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Floxuridine active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all products repackaged and distributed between January 5, 2012, and February 12, 2015. The affected product is an active pharmaceutical ingredient intended for use by compounding pharmacies and research organizations, not for direct consumer use.

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. Penicillin is a common allergen, and exposure could pose a risk to individuals with penicillin allergies.

The recall is classified as FDA Class II. Compounding pharmacies and research organizations that received this product should stop using it and contact the recalling firm for instructions on return or disposal. Consumers do not need to take action as this is an active pharmaceutical ingredient distributed to professional facilities.

The recalled product

Product
Floxuridine 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
Affected units
2,350

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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