Status
Terminated
Drug Enforcement D-0777-2023
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
Report Date
June 7, 2023
Termination Date
May 23, 2024
Product Information
- Product description
- 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
- Product quantity
- 53,424 bags
- Reason for recall
- Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to 32 clinics in SC, NC and VA.
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-0777-2023
- Event ID
- 92403
- Recall initiation date
- May 23, 2023
- Center classification date
- June 1, 2023
- Code info
- Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
- More code info
- —