The Recall Desk
HighFDA (Drugs)·D-502-2015·Announced 2015-04-29

Adapalene API Recalled for Potential Penicillin Cross Contamination

Attix Pharmaceuticals is recalling all lots of Adapalene active pharmaceutical ingredient distributed between January 2012 and February 2015 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. Per the rubric, allergen mislabeling or high-risk hazards without reported illness are classified as High (Score 3).

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Adapalene 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 product was distributed nationwide to compounding pharmacies and research organizations.

The recall was initiated because the Adapalene API was repackaged in a facility that also handled penicillin products without adequate separation. This process creates a potential for cross-contamination with penicillin. No specific illnesses or injuries have been reported in the source text.

Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on return or disposal. Consumers should not use Adapalene products prepared from this specific API if they have a known penicillin allergy.

The recalled product

Product
Adapalene 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 · allergen penicillin

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