Fresenius Kabi Recalls Sodium Chloride Vials Due to Incorrect Latex Labeling
Fresenius Kabi is recalling 23.7 million sodium chloride vials 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. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically rated as Moderate (2), as there is no reported injury or death associated with the mislabeling itself.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 23,745,300 vials of Sodium Chloride Injection, USP, 0.9%, 10 mL Single Dose Vials. The recall affects product codes 918610 and 918620, which are packaged in 25-unit trays. The product is distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to a labeling error. The product inserts, tray labels, and vial labels for the affected product codes incorrectly state that the stoppers do not contain natural rubber latex. In reality, the stoppers for the recalled batches do contain natural rubber latex.
Individuals with a known allergy to natural rubber latex should not use the affected vials. Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If you have questions about this recall, contact the manufacturer or your healthcare provider.
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.
See all 2 products in this recall →Related recalls
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