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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Avella of Deer Valley, Inc.
- Category
- Drug — Injectable Medication
- 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
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.
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