Sodium Chloride 0 recalled over manufacturing violations
- Recall date
- March 5, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Walt…
- Recall number
- D-1064-2020
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care Holdings, Inc.
- Sold / distributed
- Product was distributed throughout the United States.
Why it was recalled
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
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