The Recall Desk
HighFDA (Drugs)·D-852-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Povidone K-30 Ingredient Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Povidone K-30 pharmaceutical ingredient lots 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, which fits the rubric criterion for 'Allergen mislabeling on common allergens' or 'risk-of-harm products where injury has not yet been reported.' No illnesses or injuries are reported in the source text.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Povidone K-30 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. The source text does not specify the exact number of units affected or report any illnesses or injuries.

Consumers and healthcare professionals who have this product should contact their healthcare provider or the recalling firm for instructions on how to handle or return the material. Do not use the product if you have a known allergy to penicillin until further guidance is provided.

The recalled product

Product
Povidone K-30 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 — 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 · allergen penicillin

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