The Recall Desk
SevereFDA (Drugs)·D-744-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Ketotifen Fumarate Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling all lots of Ketotifen Fumarate active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, due to potential penicillin cross-contamination.

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 with potential for significant harm (penicillin cross-contamination) are categorized as Severe.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Ketotifen Fumarate active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all products repackaged and distributed between January 5, 2012, and February 12, 2015.

The recall was initiated because the products were 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. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Ketotifen Fumarate 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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