Fresenius Kabi Recalls Sodium Chloride Vials Due to Incorrect Latex Labeling
Fresenius Kabi is recalling 1,312,350 vials of Sodium Chloride Injection because labels incorrectly state the stoppers do not contain natural rubber latex.
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 I, but the hazard is a labeling error regarding latex content without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 1,312,350 vials of Sodium Chloride Injection, USP, 0.9%, 20 mL Single Dose Vial. The affected product is packaged in 25-unit trays and is distributed nationwide in the USA and Puerto Rico. The recall involves specific lots with expiration dates ranging from November 2018 to July 2020.
The recall is being conducted because the product insert, tray label, and vial label for product codes 918610 and 918620 incorrectly state that the stoppers do not contain natural rubber latex. In reality, the stoppers for these recalled batches do contain natural rubber latex. This is a labeling error classified as 'Labeling Not Elsewhere Classified.'
Patients and healthcare providers who have received these specific vials should check the lot numbers and expiration dates against the list provided in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund. Individuals with a known latex allergy should consult their healthcare provider regarding the use of this product.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — IV Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0363323186036
Distribution
Part of a larger recall action
This product is one of 2 recalled by Fresenius Kabi USA, LLC 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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