The Recall Desk
SevereFDA (Drugs)·D-1059-2013·Announced 2013-09-25

Avella Recalls Vancomycin and Bevacizumab Due to Sterility Concerns

Avella Specialty Pharmacy is recalling vancomycin and bevacizumab products 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, particularly given the risk of sterility failure in injectable medications.

Plain-English summary

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

The affected products include Vancomycin PF (BSS) 1%, 1 mL, manufactured by Avella of Deer Valley, Inc. The recall covers 250 units with the code 12-20130508@181 and an expiration date of 10/4/2013. These products were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the affected products and contact Avella Specialty Pharmacy at 877-782-7684 for further instructions or a refund.

The recalled product

Product
Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684
Affected units
250

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@181
  • Exp 10/4/2013

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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