Avella Recalls Bevacizumab Prefilled Syringes Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 730 prefilled syringes of Bevacizumab 2.5 mg/0.1 mL due to a lack of assurance of sterility.
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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated as Severe. While specific injuries are not listed, the lack of sterility assurance in a drug product is a significant health risk.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 730 prefilled syringes of Bevacizumab 2.5 mg/0.1 mL. The product is identified by Lot # 138-20191202@64 and has an expiration date of 05/13/19. The recall is being conducted because of a lack of assurance of sterility.
The affected product was distributed nationwide in the U.S.A. The recall is classified as Class II by the FDA. No specific illnesses or injuries are reported in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Biologic / Injectable
- Affected units
- 730
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)
- Lot #: 138-20191202@64
- Exp 05/13/19
Distribution
Distributed nationwide across the United States.
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