0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Reported: December 14, 2022 Initiated: November 22, 2022 #D-0075-2023
Product Description
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Reason for Recall
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 4,097 cases/12 bags per case
- Distribution
- Product was distributed Nationwide in the USA.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 4,097 cases/12 bags per case.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 14, 2022. Severity: Moderate. Recall number: D-0075-2023.
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