The Recall Desk
HighFDA (Drugs)·D-630-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Digoxin Ingredient Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Digoxin active pharmaceutical ingredient repackaged 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 in a pharmaceutical ingredient, which poses a significant risk of harm to penicillin-allergic individuals, but no illnesses or injuries have been reported.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Digoxin active pharmaceutical ingredient 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 is being conducted because the ingredient was repackaged in a facility that also handled penicillin products without adequate separation, creating a potential for cross-contamination with penicillin.

The affected product was distributed nationwide to compounding pharmacies and research organizations. The recall covers all lots of all products repackaged during the specified timeframe. No specific illness or injury reports are mentioned in the source text.

Consumers and healthcare professionals should check their inventory for Digoxin active pharmaceutical ingredient from Attix Pharmaceuticals with repackaging dates between January 5, 2012, and February 12, 2015. Those who have this product should stop using it and contact the recalling firm or their supplier for instructions on return or disposal.

The recalled product

Product
Digoxin 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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