Avella Recalls Bevacizumab Syringes Due to Sterility Assurance Concerns
Avella of Deer Valley is recalling 911 pre-filled Bevacizumab syringes due to a lack of assurance of sterility. The product was distributed throughout the United States.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility issue) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 911 pre-filled syringes of Bevacizumab 2.5 mg/0.1 mL (NDC 42852-001-24). The specific lot affected is # 138-20182408@58, with a beyond-use date of 12/22/2018. The product was repackaged by Avella Specialty Pharmacy in Phoenix, Arizona, and distributed throughout the United States.
The recall was initiated due to a lack of assurance of sterility. The source text does not report any specific illnesses, injuries, or fatalities associated with the use of this product.
Consumers and healthcare providers should stop using the affected syringes and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Biologic
- Hazard
- Affected units
- 911
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)
- Lot # 138-20182408@58 BUD 12/22/2018
Distribution
Distribution scope not specified by the agency.
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