The Recall Desk
HighFDA (Drugs)·D-650-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Epinephrine Ingredient Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling epinephrine active pharmaceutical ingredient distributed to compounding pharmacies and research organizations due to potential penicillin cross-contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk allergen (penicillin) cross-contamination in a pharmaceutical ingredient, which poses a significant risk of harm to sensitive individuals, but no illnesses or injuries have been reported in the source text.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of epinephrine active pharmaceutical ingredient 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 ingredient 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 illness or injury reports are mentioned in the source text.

Consumers and healthcare professionals who have received this product should contact their supplier or the recalling firm for instructions on how to return or dispose of the material. Compounding pharmacies and research organizations should verify their inventory against the distribution dates and lot information provided.

The recalled product

Product
Epinephrine 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

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 →