FDAFDA · Food and drugs·Recall number D-1064-2020
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Published March 25, 2020 · Recall initiated: March 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Product was distributed throughout the United States.
- Lot
- Lot #: 19EG02012, 19EG02019, Exp. Date 05/2020; 19DG02050, Exp. Date 04/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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