Atropine Sulfate Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Atropine Sulfate Monohydrate USP active pharmaceutical ingredient due to potential penicillin cross contamination during repackaging.
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 classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for significant harm (penicillin cross-contamination) are classified as Severe (Score 4), as they are not Class I but involve a significant hazard.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Atropine Sulfate Monohydrate USP active pharmaceutical ingredient. The product was packaged in varying grams or kilograms in bags or drums. The specific quantity involved in this recall is 7305 grams.
The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This process created the potential for cross contamination with penicillin. All lots repackaged and distributed between January 5, 2012, and February 12, 2015, are affected.
The product was distributed nationwide to compounding pharmacies and research organizations. The U.S. Food and Drug Administration has classified this as a Class II recall. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Atropine Sulfate Monohydrate USP 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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