Sodium Phenylbutyrate Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Sodium Phenylbutyrate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant hazards like cross-contamination with penicillin, which can cause severe allergic reactions.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Sodium Phenylbutyrate active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all products repackaged and distributed between January 5, 2012, and February 12, 2015.
The recall is being conducted because the products were repackaged in a facility that also handled penicillin products without adequate separation. This process created the potential for cross-contamination with penicillin.
The affected product was distributed nationwide to compounding pharmacies and research organizations. 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 recalled product
- Product
- Sodium Phenylbutyrate 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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