The Recall Desk
SevereFDA (Drugs)·D-557-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Calcium Sulfate Hemihydrate Due to Penicillin Cross-Contamination Risk

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk allergen (penicillin) cross-contamination, which meets the rubric criteria for a Severe rating due to the potential for significant injury.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Calcium Sulfate Hemihydrate active pharmaceutical ingredient. The product is packaged in varying grams or kilograms in bags or drums. The recall covers all lots repackaged and distributed between January 5, 2012, and February 12, 2015.

The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin. The FDA has classified this recall as Class II.

The affected product was distributed nationwide to compounding pharmacies and research organizations. Individuals or organizations that possess this product should contact Attix Pharmaceuticals for further instructions on how to return or dispose of the material.

The recalled product

Product
Calcium Sulfate Hemihydrate 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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