FDARecalled Jun 7, 2023 · #D-0777-2023
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Hazard
Class II — temporary health risk
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Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Classification: Class II Distribution: Product was distributed to 32 clinics in SC, NC and VA.
Product details
- Product
- Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
- Type
- Drugs
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Model numbers
- 23AU05030
- UPCs
- —