The Recall Desk
SevereFDA (Drugs)·D-759-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Levomefolate Calcium Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Levomefolate Calcium API due to potential penicillin cross-contamination from inadequate facility separation. The recall affects lots distributed nationwide to compounding pharmacies and research organizations.

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, FDA Class II recalls with potential for significant injury (penicillin cross-contamination can cause severe allergic reactions) map to a score of 4 (Severe), as it is not Class I but involves a significant hazard.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Levomefolate Calcium (L-5-Methyltetrahydrofolate Calcium) active pharmaceutical ingredient. The product was packaged in varying grams or kilograms in bags or drums. The recall covers all lots repackaged and distributed between January 5, 2012, and February 12, 2015.

The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide to compounding pharmacies and research organizations. Consumers and healthcare providers should check their inventory for this specific active pharmaceutical ingredient from Attix Pharmaceuticals and stop using it if it matches the distribution dates. No specific illness or injury reports are mentioned in the source text, but the risk of penicillin exposure is the primary concern.

The recalled product

Product
Levomefolate Calcium or L-5-Methyltetrahydrofolate Calcium 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 →

Related recalls

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Same hazard · penicillin cross contamination

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