Lactated Ringer's Injection USP
Presence of Particulate matter.
Class I — High risk. Reasonable probability of serious harm or death.
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
Compare with the code on your package — it is the most precise check available.
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Chloride NDC 00264-1800 |
9 mg/mL | Injection, Solution Intravenous |
B. Braun Medical Inc. | Rx |
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Presence of Particulate matter.
Presence of Particulate Matter.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Presence of Foreign Tablets/Capsules
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Presence of particulate matter: Particulates identified as fiberglass
Presence of Particulate matter.
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