The Recall Desk
HighFDA (Drugs)·D-598-2015·Announced 2015-04-29

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

Attix Pharmaceuticals is recalling all lots of Clozapine 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 product, which poses a significant risk of harm to sensitive individuals, but no illnesses or injuries have been reported in the source text.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Clozapine 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. The recall covers all lots of all products repackaged during the specified timeframe. No specific lot numbers are listed in the source text, but the recall applies to all units repackaged within the stated dates.

Consumers and healthcare providers should stop using the affected Clozapine API and contact their supplier or the recalling firm for further instructions. This recall is precautionary to prevent potential allergic reactions in patients sensitive to penicillin.

The recalled product

Product
Clozapine 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

See all →

Same hazard · allergen penicillin

See all →