The Recall Desk
SevereFDA (Drugs)·D-683-2015·Announced 2015-04-29

Fluorexon API Recalled for Potential Penicillin Cross Contamination

Attix Pharmaceuticals is recalling Fluorexon 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 classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the risk of penicillin cross-contamination which can cause severe allergic reactions.

Plain-English summary

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

The recall was initiated because the API 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. No specific illnesses or injuries have been reported in the source text. Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Fluorexon 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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