The Recall Desk
SevereFDA (Drugs)·D-599-2015·Announced 2015-04-29

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

Attix Pharmaceuticals is recalling colchicine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging. The product was distributed to compounding pharmacies and research organizations.

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. According to the rubric, an FDA Class II recall involving a significant hazard (penicillin cross-contamination, which can cause severe allergic reactions) without reported fatalities or hospitalizations falls under the 'Severe' category (Score 4).

Plain-English summary

Attix Pharmaceuticals is recalling all lots of colchicine 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 source text does not specify the exact number of units recalled or the specific lot numbers, noting only that all lots repackaged and distributed within the specified date range are included. No illnesses or injuries have been reported in the source text.

Consumers and healthcare professionals who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or return. Because the product is an active pharmaceutical ingredient intended for compounding and research, it is not typically sold directly to the general public.

The recalled product

Product
Colchicine 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 · penicillin cross contamination

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