The Recall Desk
SevereFDA (Drugs)·D-910-2015·Announced 2015-04-29

Tacrolimus Monohydrate Recalled for Potential Penicillin Cross Contamination

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

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, which corresponds to a Severe severity score (4) under the rubric, as it involves a potential hazard that could cause temporary or medically reversible health consequences, specifically penicillin cross-contamination.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Tacrolimus Monohydrate active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product was packaged in varying grams or kilograms in bags or drums. The recall is being conducted because the API was repackaged in a facility that also handled penicillin products without adequate separation, creating a potential for cross-contamination with penicillin.

The affected product was distributed nationwide to compounding pharmacies and research organizations. The total quantity involved in this recall is 647 grams. Because the product is an active pharmaceutical ingredient intended for compounding and research, it is not typically sold directly to consumers.

Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on how to return or dispose of the material. Patients who have already received medications compounded with this specific API should consult their healthcare provider or pharmacist for guidance on potential risks and next steps.

The recalled product

Product
Tacrolimus Monohydrate 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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