Reported Feb 1, 2023 · Terminated
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose…
Nephron Sc Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nephron Sc Inc · 4500 12th Street Ext · West Columbia, SC · 29172-3025
Is this the product you have?
- Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
- Lot codes and dates
- Lots
124081124082Exp. 04/2023224031Exp. 01/2024
- Lots
- Amount recalled
- 389,730 vials
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: potential for trace amounts of product carryover.
This product could cause temporary or reversible health problems — stop using it.
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