Class II
Ongoing
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
- Recall Initiated
- November 22, 2022
- Posted
- December 14, 2022
- Recall Number
- D-0075-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,097 cases/12 bags per case
- Firm Location
- Waltham, MA, United States
Reason for Recall
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Distribution
Product was distributed Nationwide in the USA.
Lot / Code Info
Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
More recalls by Fresenius Medical Care Holdings, Inc.
5008X CAREsystem +CLiC +CDX;
Dec 17, 2025
Optiflux High Flux E-beam Dialyzer
Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (...
Oct 3, 2025
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care Nort...
Jul 2, 2025 · Class II
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models:
a. 5008X Sta...
Jun 18, 2025
Dialyzer Optiflux 160NRe
Jan 3, 2025
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026