Attix Pharmaceuticals Recalls Iron Sucrose API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Iron Sucrose and Ferric Hydroxide Sucrose Complex active pharmaceutical ingredients due to potential penicillin cross-contamination during repackaging.
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. Per the rubric, FDA Class II recalls with potential for significant harm (penicillin cross-contamination in a pharmaceutical context) are categorized as Severe (Score 4), as Class I is required for Critical (Score 5).
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Iron Sucrose and Ferric Hydroxide Sucrose Complex active pharmaceutical ingredients (API) packaged in bags or drums. The affected products were repackaged and distributed between January 5, 2012, and February 12, 2015. The total quantity involved is 120,500 grams.
The recall is being conducted 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 FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected API was distributed nationwide to compounding pharmacies and research organizations. There are no reports of illnesses or injuries associated with this recall. Consumers and healthcare providers should contact their healthcare provider or pharmacist for guidance on the use of these products.
The recalled product
- Product
- Iron Sucrose or Ferric Hydroxide Sucrose Complex 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
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.
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