The Recall Desk
SevereFDA (Drugs)·D-937-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Tramadol HCl Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Tramadol HCl 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 classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant injury risks or hospitalization reports are classified as Severe (Score 4). Penicillin cross-contamination poses a significant risk of severe allergic reactions.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Tramadol HCl active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The recall involves 116,900 grams of the product, which was packaged in varying grams or kilograms in bags or drums.

The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This process created 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 the recalling firm for further instructions. Consumers should not use any Tramadol HCl API from this source if they have it in their possession.

The recalled product

Product
Tramadol HCl 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

Same manufacturer · Attix Pharmaceuticals

See all →

Same hazard · penicillin cross contamination

See all →