MedicaLyte Liquid Bicarbonate Concentrate recalled over foreign material
- Recall date
- April 11, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Nipro Renal Soultions USA, Corporation recalls MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corru…
- Recall number
- Z-1730-2025
- FDA classification
- Class I
- Brand / firm
- Nipro Renal Soultions USA, Corporation
- Sold / distributed
- US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, PR. International distribution to Guatemala and Panama.
Why it was recalled
Potential for the presence of visible foreign matter.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
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