The Recall Desk
ModerateFDA (Drugs)·D-0540-2021·Announced 2021-06-02

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.

What this means for you

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
Hazard
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

Distributed in 3 states:

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.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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