Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
0.25% Acetic Acid Irrigation USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
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.
What was recalled
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
Affected NDC
0264-2304-10
Compare with the code on your package — it is the most precise check available.
Product details
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 |
|---|---|---|---|---|
| Acetic Acid NDC 00264-2304 |
.25 g/100mL | Irrigant Irrigation |
B. Braun Medical Inc. | Rx |
- Recalling firm
- B. Braun Medical Inc
- NDC code
- 0264-2304-10
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0112-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by B. Braun Medical Inc
All 2017 recalls
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate matter.
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate Matter.
Class II · Moderate risk
Lactated Ringer's Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Other particulate / foreign matter recalls from 2017
All particulate / foreign matter recalls
Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of particulate matter
Class III · Low risk
Auryxia (ferric citrate)
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Class I · High risk
Pantoprazole Sodium for Injection
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
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