The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-671-2015·Announced 2015-04-29

Famciclovir Recalled Due to Potential Penicillin Cross Contamination

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

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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as cross-contamination with a major allergen (penicillin) warrants a 'Severe' rating (Score 4), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of famciclovir 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 total quantity involved in this recall is 27,302 grams.

The recall was initiated because the API was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide to compounding pharmacies and research organizations. Consumers who have purchased or possess this specific API should contact their healthcare provider or the recalling firm for further instructions on how to proceed.

The recalled product

Product
Famciclovir 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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