The Recall Desk
SevereFDA (Drugs)·D-1058-2013·Announced 2013-09-25

Avella Specialty Pharmacy Recalls Bevacizumab and Vancomycin Due to Sterility Concerns

Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns about sterility assurance with its independent testing laboratory.

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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential sterility issues.

Plain-English summary

Avella Specialty Pharmacy is recalling bevacizumab and vancomycin. The recall is being conducted due to concerns regarding sterility assurance with the specialty pharmacy's independent testing laboratory.

The specific product identified in the recall is Bevacizumab 1.25 mg/0.05 mL PF. The recall involves 750 units with the code 12-20130508@179 and an expiration date of 11/3/2013. The products were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the affected products and contact Avella Specialty Pharmacy for further instructions.

The recalled product

Product
Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684
Affected units
750

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 (2)

  • 12-20130508@179
  • Exp 11/3/2013

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Avella of Deer Valley, Inc. 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 2 products in this recall →

Same manufacturer · Avella of Deer Valley, Inc.

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