Attix Pharmaceuticals Recalls Dacarbazine Due to Penicillin Cross Contamination Risk
Attix Pharmaceuticals is recalling Dacarbazine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk allergen (penicillin) cross-contamination in a pharmaceutical product where no illnesses have been reported, meeting the criteria for a High severity score.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Dacarbazine active pharmaceutical ingredient (API) packaged in varying grams or kilograms in bags or drums. The recall covers all products repackaged and distributed between January 5, 2012, and February 12, 2015.
The recall was initiated because the Dacarbazine was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a 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. There are no reported illnesses or injuries associated with this recall. Compounding pharmacies and research organizations should stop using the product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Dacarbazine 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.
See all 470 products in this recall →Related recalls
Same manufacturer · Attix Pharmaceuticals
See all →- SevereAttix Pharmaceuticals Recalls Idebenone Due to Penicillin Cross Contamination Risk
FDA (Drugs) · 2015-04-29
- SevereAttix Pharmaceuticals Recalls Methylprednisolone Base Due to Penicillin Cross-Contamination Risk
FDA (Drugs) · 2015-04-29
- SevereCarbazochrome API Recalled for Potential Penicillin Cross Contamination
FDA (Drugs) · 2015-04-29
- SevereAttix Pharmaceuticals Recalls Cidofovir Dihydrate Due to Penicillin Cross-Contamination Risk
FDA (Drugs) · 2015-04-29
- SevereAttix Pharmaceuticals Recalls Pheniramine Maleate Due to Penicillin Cross-Contamination Risk
FDA (Drugs) · 2015-04-29
Same hazard · allergen penicillin
See all →- HighFreedom Pharmaceuticals Recalls Domperidone API Due to Penicillin Cross-Contamination
FDA (Drugs) · 2016-01-20
- HighLife Science Pharmacy Recalls TRI-EST Gels Due to Penicillin Contamination
FDA (Drugs) · 2015-12-09
- HighLife Science Pharmacy Recalls Compounded Estriol Suppositories Due to Penicillin Contamination
FDA (Drugs) · 2015-12-09
- HighLife Science Pharmacy Recalls Compounded Estriol Vaginal Creams
FDA (Drugs) · 2015-12-09
- HighLife Science Pharmacy Recalls Compounded Estriol Gels Due to Penicillin Contamination
FDA (Drugs) · 2015-12-09