Recall archive / FDA drug enforcement
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America,... — FDA record D-0777-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 23, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- 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
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 53,424 bags
- Agency-reported status
- Terminated
- Source record identifier
- D-0777-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to 32 clinics in SC, NC and VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 7, 2023
- Recall initiation date
- May 23, 2023
- Center classification date
- Jun 1, 2023
- Termination date
- May 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.