October 2018 FDA Recall Drug by Avella Of Deer Valley, Inc. Store 38
D-0224-2019 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Avella Of Deer Valley, Inc. Store 38 on October 31, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was distributed throughout the United States. and the recall is currently terminated.

Recall Number: D-0224-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-31-2018
Reported
11-14-2018
Quantity
911 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81466
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Avella of Deer Valley, Inc. Store 38
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 138-20182408@58 BUD 12/22/2018