The Recall Desk
SevereFDA (Drugs)·D-753-2015·Announced 2015-04-29

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

Attix Pharmaceuticals is recalling Levalbuterol 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 source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4; however, FDA Class II with potential for significant injury (penicillin allergy) aligns with the 'Severe' criteria for significant injury reports or high-risk contamination contexts in the rubric's upper tiers, specifically mapping Class II to a score of 4 in the absence of Class I designation but acknowledging the high-risk nature of penicillin cross-contamination.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Levalbuterol HCl 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 product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin.

The affected product was distributed nationwide to compounding pharmacies and research organizations. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Levalbuterol 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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