The Recall Desk
SevereFDA (Drugs)·D-783-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Methazolamide Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Methazolamide 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard (penicillin cross-contamination, which poses a risk of severe allergic reaction) corresponds to a severity score of 4 (Severe).

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Methazolamide active pharmaceutical ingredient (API) 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 total quantity involved in the recall is 25,522 grams.

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

Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on return or disposal. Consumers should not use this product if they have obtained it through these channels.

The recalled product

Product
Methazolamide 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

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 →