Secnidazole API Recalled for Potential Penicillin Cross-Contamination
Attix Pharmaceuticals is recalling Secnidazole active pharmaceutical ingredient 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for significant injury (penicillin cross-contamination) corresponds to a severity score of 4 (Severe).
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Secnidazole 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 the recall is 12,025 grams.
The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition created the 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 product 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 stop using the affected product and contact their supplier or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Secnidazole 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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