The Recall Desk
SevereFDA (Drugs)·D-626-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Dexmedetomidine HCI Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Dexmedetomidine HCI active pharmaceutical ingredient due to potential penicillin cross-contamination from repackaging in a shared facility.

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 FDA classified this as a Class II recall. According to the rubric, an FDA Class II recall involving a significant hazard such as cross-contamination with a major allergen (penicillin) warrants a score of 4 (Severe), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Dexmedetomidine HCI active pharmaceutical ingredient (API) 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 by the U.S. Food and Drug Administration (FDA) under recall number D-626-2015.

The recall is due to the potential for cross-contamination with penicillin. The source text states that the affected lots were repackaged in a facility that also handled penicillin products without adequate separation. This lack of separation creates a risk that penicillin could be introduced into the Dexmedetomidine HCI product.

The affected product was distributed nationwide to compounding pharmacies and research organizations. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Individuals who have received or possess this product should contact their healthcare provider or the recalling firm for instructions on how to proceed.

The recalled product

Product
Dexmedetomidine HCI 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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