Class I · High risk
Cefazolin in Dextrose
Presence of Particulate Matter
Cefazolin for Injection USP and Dextrose Injections USP (Cefazolin Sodium)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11
Affected NDC
0264-3103-11
Compare with the code on your package — it is the most precise check available.
Drug: Cefazolin
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 |
|---|---|---|---|---|
| Cefazolin Sodium NDC 00264-3103 |
1 g/50mL | Solution Intravenous |
B. Braun Medical Inc. | Rx |
- Recalling firm
- B. Braun Medical Inc
- NDC code
- 0264-3103-11
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1268-2014 · 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 Cefazolin recalls
See all
Class I · High risk
Cefazolin for Injection
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Class II · Moderate risk
ceFAZolin sodium in Sterile Water for injection
Lack of assurance of sterility.
Class II · Moderate risk
CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR
Lack of sterility assurance
Class II · Moderate risk
Cefazolin
Lack of sterility assurance
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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