Class II
Ongoing
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
This recall is currently active, issued November 5, 2025. It was issued by Otsuka Icu Medical Llc.
- Company
- Otsuka Icu Medical Llc
- Recall Initiated
- October 27, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0143-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 509,360 100 mL bags
- Firm Location
- Austin, TX, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Distribution
Distributed Nationwide in the USA.
Lot / Code Info
Lot # 1029921, Exp Date: 28 February 2027
More recalls by Otsuka Icu Medical Llc
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