Terbinafine Base Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Terbinafine Base 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk scenarios are rated as Severe (4). Penicillin cross-contamination poses a significant risk of severe allergic reactions.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Terbinafine Base active pharmaceutical ingredient 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 recall is being conducted because the material was repackaged in a facility that also handled penicillin products without adequate separation, creating a potential for cross-contamination with penicillin.
The affected product was distributed nationwide to compounding pharmacies and research organizations. The total quantity involved is 5,848 grams. No specific illnesses or injuries have been reported in the source text.
Compounding pharmacies and research organizations should stop using the affected lots and contact the recalling firm for further instructions. Consumers should not use any Terbinafine Base products from this source if they have them in their possession.
The recalled product
- Product
- Terbinafine Base 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 · penicillin cross contamination
See all →- SevereGlaxoSmithKline Recalls Bactroban Ointment Due to Penicillin Cross-Contamination
FDA (Drugs) · 2016-07-27
- SevereFDA Recalls Compounder Biest Troches Due to Penicillin Cross-Contamination
FDA (Drugs) · 2015-11-18
- SevereMeloxicam Capsules Recalled for Potential Penicillin Cross Contamination
FDA (Drugs) · 2015-09-09
- SevereAttix Pharmaceuticals Recalls Phenoxybenzamine HCl Due to Penicillin Cross-Contamination Risk
FDA (Drugs) · 2015-04-29