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.
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 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
- Manufacturer
- Avella of Deer Valley, Inc.
- Category
- Drug — Specialty Pharmacy
- Hazard
- 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
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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