The Recall Desk
SevereFDA (Drugs)·D-548-2015·Announced 2015-04-29

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

Attix Pharmaceuticals is recalling all lots of Bromhexine HCl active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, 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, which corresponds to a 'Severe' rating under the rubric. The hazard involves potential penicillin cross-contamination, which poses a significant risk of allergic reactions in sensitive individuals.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Bromhexine 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 recall covers all lots of all products repackaged and distributed during the specified timeframe. No specific lot numbers are listed in the source text, but the recall applies to all units distributed within the date range.

Consumers and healthcare providers who possess this product should stop using it and contact their supplier or the recalling firm for instructions on return or disposal. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Bromhexine 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

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Same hazard · penicillin cross contamination

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