The Recall Desk
HighFDA (Drugs)·D-0224-2019·Announced 2018-11-14

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.

What this means for you

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
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.