The Recall Desk
SevereFDA (Drugs)·D-661-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Ethinyl Estradiol Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling all lots of Ethinyl Estradiol 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 agency classification is FDA Class II. The hazard involves potential cross-contamination with penicillin, a common allergen, which poses a risk of severe allergic reactions or anaphylaxis, meeting the criteria for a Severe rating.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Ethinyl Estradiol 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 process created a potential for cross-contamination with penicillin. The affected product is an active pharmaceutical ingredient, not a finished consumer medication.

The product was distributed nationwide to compounding pharmacies and research organizations. Consumers who have purchased finished medications containing Ethinyl Estradiol should consult their healthcare provider or pharmacist for guidance, as this recall specifically targets the raw API supplied to professional facilities.

The recalled product

Product
Ethinyl Estradiol 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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