The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-610-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Dantrolene Sodium Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Dantrolene Sodium active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. Under the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the risk of severe allergic reactions from penicillin cross-contamination.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Dantrolene Sodium active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all products repackaged and distributed between January 5, 2012, and February 12, 2015. The total quantity involved is 8,447 grams.

The recall was initiated because the products were repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin. The affected API was distributed nationwide to compounding pharmacies and research organizations.

Compounding pharmacies and research organizations that received these products should stop using them and contact Attix Pharmaceuticals for further instructions. Consumers should not use Dantrolene Sodium products sourced from these specific lots if they have been dispensed to them.

The recalled product

Product
Dantrolene Sodium 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
Category
Drug — Active Pharmaceutical Ingredient
Hazard

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 →

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