The Recall Desk
ModerateFDA (Drugs)·D-0462-2021·Announced 2021-06-02

Cardinal Health Recalls Sodium Sulfacetamide and Sulfur Cleanser Due to Temperature Excursions

Cardinal Health Inc. is recalling 16 tubes of Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser 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 injuries or illnesses, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 16 tubes of Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser, 10 oz. (285 g), NDC 50096-502-10. The product was manufactured for Rosemar Labs, LLC. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. The specific code information for the recalled units is 59314. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.

The recalled product

Product
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027
Manufacturer
Cardinal Health Inc.
Category
Drug — Topical Cleanser
Hazard
Affected units
16

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)

  • 59314

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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