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Recall Observatory FDA recall evidence

Drug product

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

D-0075-2023

November 22, 2022

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 91226
Status
Ongoing
Classification
Class II
Quantity
4,097 cases/12 bags per case
Official record key
drug-enforcement:D-0075-2023

Official wording

Reason: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Code information: Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023

Distribution pattern: Product was distributed Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility