The Recall Desk
SevereFDA (Drugs)·D-834-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Paroxetine HCl Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Paroxetine HCl 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. Per the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated Severe (4). While no injuries are reported, the potential for penicillin cross-contamination in a pharmaceutical context presents a significant risk of severe allergic reactions, aligning with the 'Severe' criteria for significant injury potential or high-risk contamination in a Class II context.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Paroxetine HCl 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 because the API 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 source text does not specify the exact number of units recalled or the specific lot numbers, noting only that all lots repackaged and distributed during the specified timeframe are included. No 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 the recalling firm for instructions on return or disposal. Consumers should not use this active pharmaceutical ingredient, as it is intended for professional use in the preparation of medications.

The recalled product

Product
Paroxetine HCl 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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