Status
Ongoing
Drug Enforcement D-0075-2023
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Classification
Class II
Report Date
December 14, 2022
Termination Date
—
Product Information
- 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
- Product quantity
- 4,097 cases/12 bags per case
- Reason for recall
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed Nationwide in the USA.
Location & Firm
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Address
-
920 Winter St Bld 950, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0075-2023
- Event ID
- 91226
- Recall initiation date
- November 22, 2022
- Center classification date
- December 2, 2022
- Code info
- Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
- More code info
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