Purdue Pharma Recalls Betadine Swabsticks Due to Subpotent Drug Hazard
Purdue Pharma is recalling Betadine Povidone-Iodine swabsticks because a manufacturing error caused the product to be subpotent.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Purdue Pharma, LP is recalling Betadine (Povidone-Iodine) Solution Swabsticks. The recall involves 3,997 swabsticks distributed nationwide in the USA. The specific lots affected are 62823 (Exp. 12/31/18), 64304 (Exp. 05/31/2019), 64711 (Exp. 08/31/2019), and 65915 (Exp. 12/31/2019).
The recall was initiated because the product is subpotent. The laminate used to make the pouches was reversed, causing the aluminum layer to come into contact with the product. This contact triggered an exothermic reaction between the free iodine and the aluminum, resulting in a loss of potency.
Consumers and healthcare providers should stop using the affected swabsticks and contact Purdue Pharma for a refund or replacement. The product is an over-the-counter antiseptic used for topical application.
The recalled product
- Product
- BETADINE (POVIDONE-IODINE)
- Brand
- BETADINE
- Manufacturer
- Purdue Pharma, LP
- Category
- Drug — Topical Antiseptic
- Affected units
- 3,997
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)
- Lots: 62823 Exp. 12/31/18
- 64304 Exp. 05/31/2019
- 64711 Exp. 08/31/2019
- 65915 Exp. 12/31/2019
Distribution
Distributed nationwide across the United States.
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