The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-573-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Cetirizine HCI Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Cetirizine HCI active pharmaceutical ingredient due to potential penicillin cross-contamination. The product was distributed to compounding pharmacies and research organizations.

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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of severe allergic reactions from penicillin cross-contamination.

Plain-English summary

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

The recall is being conducted because the products were repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the 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 recalled product and contact their supplier or the recalling firm for further instructions.

The recalled product

Product
Cetirizine HCI 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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