Attix Pharmaceuticals Recalls Ofloxacin Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Ofloxacin 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury risks (such as anaphylaxis from penicillin cross-contamination) are categorized as Severe.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Ofloxacin active pharmaceutical ingredient (API) packaged in bags or drums. The product was repackaged and distributed between January 5, 2012, and February 12, 2015.
The recall is being conducted because the Ofloxacin was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin, which poses a risk to patients with penicillin allergies.
The affected product was distributed nationwide to compounding pharmacies and research organizations. Consumers and healthcare providers should stop using the product and contact the recalling firm or their supplier for further instructions.
The recalled product
- Product
- Ofloxacin 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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