Reported Jun 20, 2012 · Terminated
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY…
Luitpold Pharmaceuticals, 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: Luitpold Pharmaceuticals, Inc. · One Luitpold Drive · Shirley, NY · 11967-9001
Is this the product you have?
- CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
- Lot codes and dates
- 30
- mL Lots
91989252929993059402942394329553959596469681973797979831005100950362100
- mL Lots
92259492971100070058
- Amount recalled
- 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
This product could cause temporary or reversible health problems — stop using it.
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