The Recall Desk
SevereFDA (Drugs)·D-537-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Benazepril HCl Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Benazepril HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

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. The hazard involves potential penicillin cross-contamination, which can cause severe allergic reactions (anaphylaxis) in sensitive individuals, meeting the criteria for a Severe rating due to the high-risk nature of the contaminant.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Benazepril HCl 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. 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 3,999 grams. No specific illnesses or injuries have been reported in the source text, but the presence of penicillin contamination poses a significant risk of severe allergic reactions for sensitive individuals.

Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on return or disposal. Consumers should not use any Benazepril HCl API from this source if they have it in their possession.

The recalled product

Product
Benazepril HCl 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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