The Recall Desk
SevereFDA (Drugs)·D-531-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Azatadine Maleate Due to Penicillin Cross-Contamination Risk

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

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, which corresponds to a 'Severe' rating under the rubric, as it involves a potential for adverse health consequences (penicillin cross-contamination) that may cause temporary or medically reversible harm.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Azatadine Maleate 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 is being conducted because the API 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. No specific lot numbers are listed in the source text, but the recall covers all lots repackaged and distributed within the specified date range. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare professionals who have purchased or received this product should stop using it and contact their supplier or the recalling firm for instructions on return or disposal. Individuals with known penicillin allergies should exercise particular caution and consult with a healthcare provider if they have been exposed to the product.

The recalled product

Product
Azatadine Maleate 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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