The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-546-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Bovine Insulin Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling all lots of Bovine Insulin active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, due to potential penicillin cross-contamination.

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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm (penicillin cross-contamination in a drug product) align with a score of 4 (Severe), as Class I is required for score 5 and Class III is typically 1-2.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Bovine Insulin 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 covers all lots of all products distributed during this specific timeframe.

The recall was initiated because the Bovine Insulin API was repackaged in a facility that also handled penicillin products without adequate separation. This process created a potential for cross-contamination with penicillin. The agency has classified this recall as Class II.

The affected product was distributed nationwide to compounding pharmacies and research organizations. No specific illness or injury reports are mentioned in the source text. Consumers and healthcare providers should stop using the affected product and contact their supplier or the recalling firm for further instructions.

The recalled product

Product
Bovine Insulin 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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