Attix Pharmaceuticals Recalls Clomiphene Citrate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Clomiphene Citrate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
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 and involves a high-risk allergen (penicillin) cross-contamination, which poses a significant risk of severe allergic reactions or anaphylaxis to sensitive individuals, meeting the criteria for a Severe rating.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Clomiphene Citrate active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers products repackaged and distributed between January 5, 2012, and February 12, 2015. The product was distributed nationwide to compounding pharmacies and research organizations.
The recall was initiated because the API was repackaged in a facility that also handled penicillin products. The facility lacked adequate separation between the products, creating a potential for cross-contamination with penicillin. This contamination risk is significant for individuals with penicillin allergies.
Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for further instructions. Consumers should not use any Clomiphene Citrate products derived from this recalled API if they have a known penicillin allergy.
The recalled product
- Product
- Clomiphene Citrate 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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