The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-813-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Naproxen Sodium Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Naproxen Sodium active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 poses a significant risk of severe allergic reactions, meeting the criteria for a Severe rating.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Naproxen Sodium active 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 product 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 is classified as Class II by the U.S. Food and Drug Administration. No specific illnesses or injuries have been reported in the source text, but the presence of penicillin in a naproxen product poses a risk of severe allergic reactions for patients with penicillin allergies.

Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on return or disposal. Patients who have received medications containing this specific ingredient should consult their healthcare provider if they have a known penicillin allergy.

The recalled product

Product
Naproxen Sodium 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 →

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