Attix Pharmaceuticals Recalls Pregelatinized Starch Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Pregelatinized Starch pharmaceutical ingredients 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 ingredient. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Pregelatinized Starch pharmaceutical ingredients that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product is packaged in varying grams or kilograms in bags or drums.
The recall is being conducted because the ingredients were repackaged in a facility that also handled penicillin products without adequate separation. This process creates a potential for cross-contamination with penicillin.
The affected products were distributed nationwide to compounding pharmacies and research organizations. The source text does not specify the number of affected units or report any illnesses or injuries.
The recalled product
- Product
- Pregelatinized Starch 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
- Category
- Drug — Pharmaceutical Ingredient
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