The Recall Desk
SevereFDA (Drugs)·D-602-2015·Announced 2015-04-29

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

Attix Pharmaceuticals is recalling crospovidone pharmaceutical ingredient distributed nationwide to compounding pharmacies and research organizations due to potential penicillin cross-contamination.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm (such as penicillin cross-contamination which can cause severe allergic reactions) align with a Severe rating, particularly given the lack of reported illnesses but high-risk nature of the contaminant.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of crospovidone pharmaceutical ingredient 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 affects 10,500 grams of the ingredient.

The recall is being conducted because the product was repackaged in a facility that also handled penicillin products without adequate separation. This process created a potential for cross-contamination with penicillin. The affected lots were distributed nationwide to compounding pharmacies and research organizations.

Consumers and healthcare professionals should stop using the recalled crospovidone ingredient and contact their supplier or the recalling firm for instructions on return or disposal. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Crospovidone 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 — 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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