Reported Aug 24, 2022 · Terminated
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL…
Nephron Sterile Compounding Center LLC
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 Sterile Compounding Center LLC · 4500 12th Street Ext · West Columbia, SC · 29172-3025
Is this the product you have?
- PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
- Lot codes and dates
- Lot
NE1057AExp. 10/23/2022
- Lot
- Amount recalled
- 13,500 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 cross-contamination due to product carryover during manufacturing.
This product could cause temporary or reversible health problems — stop using it.
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