The Recall Desk
SevereFDA (Drugs)·D-768-2015·Announced 2015-04-29

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

Attix Pharmaceuticals is recalling Lomustine active pharmaceutical ingredient distributed 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury risks (such as anaphylaxis from penicillin cross-contamination) are categorized as Severe.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Lomustine 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 and distributed nationwide to compounding pharmacies and research organizations.

The recall was initiated because the Lomustine API was repackaged in a facility that also handled penicillin products without adequate separation. This condition created the potential for cross-contamination with penicillin, which poses a risk to patients with penicillin allergies.

Compounding pharmacies and research organizations that received the product should stop using the affected lots and contact the recalling firm for instructions on return or disposal. Consumers should not use Lomustine API from this source if they have a known penicillin allergy.

The recalled product

Product
Lomustine 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 · penicillin cross contamination

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