The Recall Desk
SevereFDA (Drugs)·D-819-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Nitrofurantoin Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Nitrofurantoin active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging. The recall affects lots distributed nationwide 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. Per the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as anaphylaxis from penicillin cross-contamination in sensitive individuals) are categorized as Severe (Score 4), particularly given the strict rule that FDA Class I/II classifications generally map to Severe or Critical levels depending on reported harm.

Plain-English summary

Attix Pharmaceuticals is voluntarily recalling all lots of Nitrofurantoin active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product is 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 total quantity involved in the recall is 5,025 grams. The FDA has classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on how to return or dispose of the recalled material. Consumers who have obtained medications containing this specific API from a compounding pharmacy should consult their healthcare provider or pharmacist for guidance on whether they need to stop taking the medication or obtain a replacement.

The recalled product

Product
Nitrofurantoin 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 · cross contamination

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