The Recall Desk
HighFDA (Drugs)·D-769-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Loratadine API Due to Penicillin Cross-Contamination Risk

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of harm from a common allergen (penicillin) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Loratadine 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 Loratadine API was repackaged in a facility that also handled penicillin products. The facility lacked adequate separation between the two products, creating a potential for cross-contamination with penicillin. Penicillin is a common allergen, and exposure could pose a risk to individuals with penicillin allergies.

The affected product was distributed nationwide to compounding pharmacies and research organizations. Consumers and healthcare providers should check their inventory for Loratadine API from Attix Pharmaceuticals distributed during the specified period and stop using it if found.

The recalled product

Product
Loratadine 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 · allergen penicillin

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