September 2019 FDA Recall Drug by Avella Of Deer Valley, Inc. Store 38
D-0152-2020 - Lack of sterility assurance.

This Class II drug recall was initiated by Avella Of Deer Valley, Inc. Store 38 on September 18, 2019 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0152-2020

Reason for Recall
Lack of sterility assurance.
Initiated
09-18-2019
Reported
10-30-2019
Quantity
808 droptainers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83833
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
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2019
Product Description About Product Description
Full technical description of the product.
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20

Batch or Lot Expiration Information

Lot# : 138-20190205@3, Exp . Date 10/29/2019; 138-20190705@7, Exp. Date 11/3/2019