Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Cefepime for Injection USP and Dextrose Injection USP (Cefepime Hydrochloride)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
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
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11
Affected NDC
0264-3193-11
Compare with the code on your package — it is the most precise check available.
Drug: Cefepime
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 |
|---|---|---|---|---|
| Cefepime Hydrochloride and Dextrose Cefepime Hydrochloride NDC 00264-3193 |
1 g/50mL | Injection, Solution Intravenous |
B. Braun Medical Inc. | Rx |
- Recalling firm
- B. Braun Medical Inc
- NDC code
- 0264-3193-11
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1054-2014 · FDA notice
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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cefepime recalls
See all
Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Other recalls by B. Braun Medical Inc
All 2013 recalls
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
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.
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