The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-727-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Ibuprofen Ingredient Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling ibuprofen 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 agency classification is FDA Class II, and the hazard involves potential penicillin cross-contamination, which poses a significant risk of severe allergic reactions or anaphylaxis, meeting the criteria for a Severe rating.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of ibuprofen active pharmaceutical ingredient (API) repackaged and distributed between January 5, 2012, and February 12, 2015. The product was packaged in varying grams or kilograms in bags or drums.

The recall is being conducted because the ibuprofen was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a potential for cross-contamination with penicillin. The affected product was distributed nationwide to compounding pharmacies and research organizations.

Consumers and healthcare professionals should stop using the affected ibuprofen API and contact their supplier or the recalling firm for instructions on return or disposal.

The recalled product

Product
Ibuprofen 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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