The Recall Desk
ModerateFDA (Drugs)·D-707-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Homatropine Methylbromide Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Homatropine Methylbromide active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported and the hazard is theoretical (potential cross-contamination), which aligns with the 'Moderate' severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Homatropine Methylbromide 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 specific quantity involved in this recall is 940 grams. Compounding pharmacies and research organizations that received this product should stop using it and contact the recalling firm for instructions on return or disposal.

This recall is classified as FDA Class II. There are no reported illnesses or injuries associated with this recall. The hazard is theoretical, based on the potential for penicillin cross-contamination in a facility that did not maintain adequate separation between products.

The recalled product

Product
Homatropine Methylbromide 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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