The Recall Desk
SevereFDA (Drugs)·D-838-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Pheniramine Maleate Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Pheniramine Maleate 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. According to the rubric, an FDA Class II recall involving a high-risk allergen (penicillin) that could cause significant injury (anaphylaxis) in sensitive individuals warrants a 'Severe' rating (Score 4), as it exceeds the threshold for 'High' (theoretical risk without reported illness) but does not meet the criteria for 'Critical' (no reported deaths or FDA Class I classification).

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Pheniramine Maleate 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 product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin, which poses a risk of severe allergic reactions for individuals with penicillin allergies.

Compounding pharmacies and research organizations that received the affected product should stop using it and contact Attix Pharmaceuticals for instructions on return or disposal. Consumers should not use any Pheniramine Maleate API from this source if they have a known penicillin allergy.

The recalled product

Product
Pheniramine Maleate 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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