Fresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
Fresenius Medical Care is recalling 25,356 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 25,356 bags of 0.9% Sodium Chloride Injection, USP, 1000 mL. The product is identified by NDC 49230-0300-10, Lot # 17LU05005, and an expiration date of 09/18. The recall was initiated due to a lack of assurance of sterility.
The affected product was distributed throughout the United States. The source text does not specify specific states or facilities where the product was shipped, only that distribution was nationwide.
Healthcare providers and patients should stop using the affected product and contact the manufacturer or their supplier for further instructions. The source text does not provide specific contact information or a return address for the recalled items.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
- Category
- Drug — Injectable Solution
- Hazard
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 (2)
- Lot # 17LU05005
- Exp. 09/18 Part Number 060-10109
Distribution
Distribution scope not specified by the agency.
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