Avella Recalls Povidone Iodine Ophthalmic Solution Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 808 droptainers of Povidone Iodine, 5% Ophthalmic Solution due to a lack of sterility assurance.
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, and the rubric specifies that FDA Class II recalls involving significant injury or structural defects are Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an ophthalmic product presents a significant risk of harm, aligning with the Severe criteria for high-risk products where injury has not yet been reported but the hazard is significant.
Plain-English summary
Avella of Deer Valley, Inc. Store 38 is recalling 808 droptainers of Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer. The product was repackaged by Avella Specialty Pharmacy in Phoenix, Arizona, and distributed nationwide within the United States.
The recall was initiated due to a lack of sterility assurance. The affected product is identified by NDC 42852-006-20. Specific lot numbers include 138-20190205@3 with an expiration date of 10/29/2019, and 138-20190705@7 with an expiration date of 11/3/2019.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the source of supply or the recalling firm.
The recalled product
- 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
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 808
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 (4)
- Lot #: 138-20190205@3
- Exp . Date 10/29/2019
- 138-20190705@7
- Exp. Date 11/3/2019
Distribution
Distributed nationwide across the United States.
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