CLASS II Drug recall · Reported 30 Oct 2019 · FDA Enforcement Report
Povidone Iodine, 5% Ophthalmic Solution per droptainer recalled
Avella of Deer Valley Inc. Store 38 is recalling Povidone Iodine, 5% Ophthalmic Solution per droptainer, distributed nationwide in the US. The recall was initiated on 18 Sep 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0152-2020
- FDA event ID
- 83833
- Recalling firm
- Avella of Deer Valley Inc. Store 38, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Sep 2019
- FDA classified
- 18 Oct 2019
- Reported
- 30 Oct 2019
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 18 Sep 2019 | Recall initiated by company | |
| 18 Oct 2019 | Classified by FDA | +30 days |
| 30 Oct 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lot #: 138-20190205@3, Exp . Date 10/29/2019; 138-20190705@7, Exp. Date 11/3/2019
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Avella of Deer Valley Inc. Store 38
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bevacizumab 2.5 mg recalled by Avella of Deer Valley, Inc. | Avella of Deer Valley Inc. Store 38 | Sterility | Nationwide |
| Drug | CLASS II | MAGnesium 2gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
| Drug | CLASS II | MAGnesium 1gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
| Drug | CLASS II | Labetalol 20mg, HCL, USP Injectable Solution, 20mg recalled | Avella of Deer Valley Inc. Store 38 | Packaging Defects | 13 states |
| Drug | CLASS II | MAGnesium 2 gm sulfate, added to NS, Sterile single use recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
Other Povidone Iodine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, (Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | Povi-One, 10% Povidone-Iodine Oral Antiseptic recalledPovi-one | Elevate Oral Care | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |