Drug recall: Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th…

Class II FDA enforcement event 83833. Recall start date: 18 Sep 2019. Status in the FDA record: Terminated. Termination date: 4 Dec 2019.

Reason for recall, in the words of FDA

Lack of sterility assurance.

Class II, in the words of FDA

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

Avella of Deer Valley, Inc. Store 38 started this drug recall on 18 Sep 2019. The firm address in the FDA record is in Phoenix, AZ. FDA put the recall in Class II. FDA event 83833 has 1 product record. The first FDA enforcement report date is 30 Oct 2019. The record gives the status Terminated, with the termination date 4 Dec 2019.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide within the United States

Recalling firm

Avella of Deer Valley, Inc. Store 38, Phoenix, AZ.

Recalling firm: The firm that the FDA record names for a recall.

Products

1 product record in the event.

FDA event 83833: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0152-2020	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	808 droptainers	Class II	Terminated	30 Oct 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2019: 362
Share of these events in Class II: 68%
Product records in this event: 1Median of the firm: 4
Events of the firm on the register: 6

Other events of the firm

Other FDA enforcement events of Avella of Deer Valley, Inc. Store 38
Initiated	Product (first record)	Type	Class	Records
3 May 2019	Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOE	Drug	Class II	1
8 Feb 2019	Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Speci	Drug	Class II	4
31 Oct 2018	BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Speci	Drug	Class II	1
19 Oct 2018	Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley,	Drug	Class II	5
12 Jun 2018	0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For:	Drug	Class II	38

Avella of Deer Valley, Inc. Store 38: all 6 events

Official channels

FDA enforcement report D-0152-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 83833. https://recallregister.com/fda/ii/83833/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide within the United States
What quantity of product is in FDA event 83833?: The FDA record gives this quantity: 808 droptainers
How many drug recalls of 2019 have the same class?: 68% of the 362 drug events that started in 2019 are in Class II.
How many FDA recalls does Avella of Deer Valley, Inc. Store 38 have?: Avella of Deer Valley, Inc. Store 38 is the recalling firm in 6 enforcement events on this register. This event is 1 of them.