The Recall Desk
SevereFDA (Drugs)·D-656-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Estriol Due to Penicillin Cross-Contamination Risk

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

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. According to the rubric, FDA Class II recalls with potential for significant injury (such as severe allergic reactions from penicillin cross-contamination) are categorized as Severe.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Estriol active pharmaceutical ingredient that were repackaged and distributed between January 5, 2012, and February 12, 2015. 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 consists of Estriol active pharmaceutical ingredient packaged in varying grams or kilograms in bags or drums. The total quantity involved in the recall is 8,045 grams. The product was distributed nationwide to compounding pharmacies and research organizations.

Consumers and healthcare professionals who have received this product should stop using it and contact their supplier or the recalling firm for further instructions. This recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Estriol 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 · cross contamination

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