The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-894-2015·Announced 2015-04-29

Silver Sulfadiazine Recalled for Potential Penicillin Cross Contamination

Attix Pharmaceuticals is recalling Silver Sulfadiazine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk allergen (penicillin) cross-contamination hazard where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Silver Sulfadiazine active pharmaceutical ingredient (API) packaged in bags or drums. The product was distributed nationwide to compounding pharmacies and research organizations 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 process created a potential for cross-contamination with penicillin.

Compounding pharmacies and research organizations that received the product should stop using it and contact the recalling firm for instructions on return or disposal. Consumers should not use this active pharmaceutical ingredient, which is typically used by professionals to create final medication products.

The recalled product

Product
Silver Sulfadiazine 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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