Cardinal Health Recalls Atropine Sulfate Ophthalmic Solution Due to Temperature Excursions
Cardinal Health Inc. is recalling 424 bottles of Atropine Sulfate Ophthalmic Solution 1% 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 and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 424 bottles of Atropine Sulfate Ophthalmic Solution, USP 1% (NDC 17478-215-05). The product is a sterile 5 mL solution intended for topical application to the eye and is available by prescription only. The bottles were manufactured by Akorn, Inc.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product has a code of 071520A. The distribution pattern indicates the product was shipped to Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 424
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)
- 071520A
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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