The Recall Desk
SevereFDA (Drugs)·D-583-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Cidofovir Anhydrous Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Cidofovir Anhydrous active pharmaceutical ingredient due to a risk of penicillin cross-contamination during repackaging.

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 significant injury or hospitalization reports, or structural defects, are Severe. While no specific injuries are reported in the text, the potential for severe allergic reactions (anaphylaxis) from penicillin cross-contamination in a pharmaceutical context aligns with the Severe tier for significant risk.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Cidofovir Anhydrous active 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 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 product was distributed nationwide to compounding pharmacies and research organizations. 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.

The recalled product

Product
Cidofovir Anhydrous 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

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 →