The Recall Desk
HighFDA (Drugs)·D-503-2015·Announced 2015-04-29

Adenosine API Recalled for Potential Penicillin Cross Contamination

Attix Pharmaceuticals is recalling Adenosine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

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 hazard where no illnesses or injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Adenosine active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all products repackaged and distributed between January 5, 2012, and February 12, 2015.

The recall was initiated because the Adenosine API 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 in sensitive individuals.

The affected product was distributed nationwide to compounding pharmacies and research organizations. There are no reported illnesses or injuries associated with this recall. Compounding pharmacies and research organizations should stop using the product and contact Attix Pharmaceuticals for further instructions.

The recalled product

Product
Adenosine 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 →