The Recall Desk
HighFDA (Drugs)·D-522-2015·Announced 2015-04-29

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

Attix Pharmaceuticals is recalling Anastrozole 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. While no illnesses are reported, the potential for severe allergic reactions in sensitive individuals places this in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Anastrozole active pharmaceutical ingredient (API) packaged in bags or drums. The product was distributed nationwide to compounding pharmacies and research organizations between January 5, 2012, and February 12, 2015.

The recall was initiated because the product was repackaged in a facility that also handled penicillin products. The facility lacked adequate separation between the two products, creating a potential for cross-contamination with penicillin. This contamination could pose a risk to individuals with penicillin allergies.

Compounding pharmacies and research organizations that received the product should stop using it and contact Attix Pharmaceuticals for instructions on return or disposal. Consumers should not use any Anastrozole products derived from this recalled API.

The recalled product

Product
Anastrozole 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

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Same hazard · allergen penicillin

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