The Recall Desk
SevereFDA (Drugs)·D-948-2015·Announced 2015-04-29

Valacyclovir HCl Recalled for Potential Penicillin Cross Contamination

Attix Pharmaceuticals is recalling Valacyclovir 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential cross-contamination with a high-risk allergen like penicillin, even if no specific hospitalization reports are detailed in the provided text.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Valacyclovir HCl 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 recall is being conducted because the API was repackaged in a facility that also handled penicillin products without adequate separation, creating a potential for cross-contamination with penicillin.

The affected product was distributed nationwide to compounding pharmacies and research organizations. The total quantity involved is 3,050 grams. Because the product is an active pharmaceutical ingredient intended for compounding and research, it is not typically sold directly to consumers. Compounding pharmacies and research organizations should stop using the affected lots and contact the recalling firm for instructions on return or disposal.

This recall is classified as Class II by the FDA, indicating 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.

The recalled product

Product
Valacyclovir 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

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Same hazard · penicillin cross contamination

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