The Recall Desk
HighFDA (Drugs)·D-581-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Chlorpromazine HCl Due to Penicillin Cross-Contamination Risk

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

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 severe allergic reactions, but no illnesses or injuries have been reported in the source text.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Chlorpromazine HCl active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product was 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 and distributed during the specified timeframe. No specific lot numbers are listed in the source text, but the recall applies to all units distributed within the date range.

Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for further instructions. Consumers should not use any Chlorpromazine HCl API from this source if they have it in their possession, as it may contain penicillin cross-contamination.

The recalled product

Product
Chlorpromazine HCl 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 →

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Same hazard · allergen penicillin

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