The Recall Desk
SevereFDA (Drugs)·D-685-2015·Announced 2015-04-29

Fluphenazine Decanoate Recalled for Potential Penicillin Cross Contamination

Attix Pharmaceuticals is recalling Fluphenazine Decanoate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for significant harm (penicillin cross-contamination) are classified as Severe (Score 4), especially given the strict rule that FDA Class I/II classifications generally warrant higher severity scores when significant injury potential exists.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Fluphenazine Decanoate active pharmaceutical ingredient (API) packaged in bags or drums. The product was repackaged and distributed between January 5, 2012, and February 12, 2015. The recall is due to the potential for cross-contamination with penicillin, as the repackaging occurred in a facility handling penicillin products without adequate separation.

The affected product was distributed nationwide to compounding pharmacies and research organizations. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the contamination.

Consumers and healthcare providers should stop using the affected product and contact their supplier or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Fluphenazine Decanoate 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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