Class II
Terminated
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
This recall has been terminated (originally issued March 25, 2020).
- Recall Initiated
- March 5, 2020
- Posted
- March 25, 2020
- Recall Number
- D-1064-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 32,592 bags
- Firm Location
- Waltham, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Distribution
Product was distributed throughout the United States.
Lot / Code Info
Lot #: 19EG02012, 19EG02019, Exp. Date 05/2020; 19DG02050, Exp. Date 04/2020
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