Cardinal Health Recalls HySept Solution Due to Temperature Excursions
Cardinal Health is recalling 236 bottles of HySept Solution 0.25% Sodium Hypochlorite due to intermittent temperature excursions during storage.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations (temperature excursions) without reported illnesses, fitting the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Cardinal Health Inc. is recalling 236 bottles of HySept Solution 0.25% Sodium Hypochlorite Solution, 473 mL (16 fl. oz.), NDC 39328-063-25. The product was manufactured by Patrin Pharma in Skokie, IL, and distributed to Florida, Georgia, and South Carolina between February 23, 2021, and March 10, 2021.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The FDA has classified this as a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers who have this product should stop using it and contact Cardinal Health or their supplier for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Antiseptic
- Affected units
- 236
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 (1)
- All Lots distributed 02/23/2021 through 03/10/2021.
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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